Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1038671

FEI Number

1038671

Entity Name

EXACTECH, INC.

City/State/Country

GAINESVILLE, FL, US

Establishment Address

2320 N.W. 66TH CT., GAINESVILLE, FL 32653, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EXACTECH, INC. (Owner Number: 1038671)

Owner / Operator Contact Address

2320 NW 66TH CT, --, Gainesville, FL 32653, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K101981

PMA Number

N/A

All Registered Proprietary Names

Equinoxe Fixed Angle Replicator Plates Equinoxe Cast Glenospheres Equinoxe Cast Humeral Heads TEMPLATE Guide Orthopaedic Bone curette, reusable EXACTECH SURGICAL SCREWDRIVER EPIC BROACH Osteotome TRULIANT® Novation 12/14 Press Fit Femrl Stem Vantage Equinoxe Optecure +CCC KNEE ORTHOPEDIC SURGICAL INSTRUMEN EXACTECH HIP TS Truliant PS Cemented Femoral, size 6 Right Truliant PS Cemented Femoral, size 5 Right Truliant CR Cemented Femoral, size 1 Left Truliant CR Cemented Femoral, size 2.5 Right Truliant PS Cemented Femoral, size 0 Left Truliant PS Cemented Femoral, size 0 Right Truliant CR Cemented Femoral, size 5 Right Truliant CR Cemented Femoral, size 3.5 Left Truliant PS Cemented Femoral, size 1.5 Right Truliant CR Cemented Femoral, size 1.5 Left Truliant CR Cemented Femoral, size 3 Right Truliant PS Cemented Femoral, size 1 Left Truliant CR Cemented Femoral, size 3 Left Truliant Cemented Femoral Component Truliant PS Cemented Femoral, size 3 Left Truliant PS Cemented Femoral, size 3.5 Right Truliant CR Cemented Femoral, size 2.5 Left Truliant CR Cemented Femoral, size 0 Left Truliant PS Cemented Femoral, size 1.5 Left Truliant CR Cemented Femoral, size 1 Right Truliant CR Cemented Femoral, size 4 Left Truliant PS Cemented Femoral, size 2 Left Truliant PS Cemented Femoral, size 4 Left Truliant CR Cemented Femoral, size 2 Left Truliant PS Cemented Femoral, size 4 Right Truliant CR Cemented Femoral, size 0 Right Truliant CR Cemented Femoral, size 5 Left Truliant CR Cemented Femoral, size 2 Right Truliant PS Cemented Femoral, size 1 Right Truliant PS Cemented Femoral, size 5 Left Truliant PS Cemented Femoral, size 2.5 Left Truliant CR Cemented Femoral, size 3.5 Right Truliant PS Cemented Femoral, size 6 Left Truliant PS Cemented Femoral, size 3.5 Left Truliant PS Cemented Femoral, size 2.5 Right Truliant PS Cemented Femoral, size 2 Right Truliant CR Cemented Femoral, size 6 Right Truliant CR Cemented Femoral, size 6 Left Truliant CR Cemented Femoral, size 1.5 Right Truliant PS Cemented Femoral, size 3 Right Truliant CR Cemented Femoral, size 4 Right AcuMatch A-Series Enhnced Polyethyl Equinoxe EXTRACTOR Equinoxe Fracture Plate Optetrak Constrained Condylar Knee Equinoxe Preserve Stem OPTETRAK UNICONDYLAR KNEE Equinoxe Equinoxe FEMORAL STEM DRIVER Novation Element Press-Fit Femoral Stem Novation Element Press Fit Stem Alteon Monobloc Revision Stem Equinoxe Extra Short Humeral Heads Equinoxe Optetrak Proximal Tibial Spacer Equinoxe Stemless Shoulder EPIC Equinoxe Exactech Total Hip System Cruciate Retaining Cemented Knee Equinoxe Rev. Shoulder Fracture Hum Orthopaedic implant/instrument dismantling device Novation Crown Cup EPIC Equinoxe UHMWPE Posterior Augment Pegged Glenoids Equinoxe Exactech Optetrak Logic CC Knee System AcuMatch M-Series ExSml Metaphyseal Novation InteGrip Acetabular Augments Vantage Mobile Bearing Ankle Femoral Heads and Novation Crown Cup Acetabular Liners Cruciate Retaining Cemented Tibial Exactech Novation XLE Acetabular Liners Exactech AcuMatch XLE Acetabular Liners Orthopaedic Bone file/rasp, manual Equinoxe Novation Element Reduced Offet Press-Fit Femoral Stems Equinoxe Laser Cage Glenoid Equinoxe UHMWPE 16 degree Posterior Augment Pegged Glenoids Postr Stablizd Cementd CoCr UHMWPE EXACTECH IMPACTOR Novation Empire Acetabular Augments with InteGrip Novation Crown Cup and Liners 12/14 Alumina Femoral Head AcuMatch MSeries 12/14 Neck Segment EXACTECH TIBIAL TAMPS Equinoxe Reverse Shoulder System Logic PS Novation Tapered 12/14 Press-Fit Femoral Stem EPIC Optecure Dental +CCC Optecure Dental Novation LPI Prime Femoral Stems Alteon® HA Femoral Stems OPTECURE Tibial Bone Removal Screw Equinoxe Reverse Shoulder Superior Augment Glenoid Plate Equinoxe Reverse Shoulder 38mm and 42mm Glensopheres Equinoxe Reverse Shoulder Glenoid Plate Equinoxe Reverse Shoulder Compression Screw Equinoxe Reverse Shoulder Posterior Augment Glenoid Plate BRACE Exactech Equinoxe 12degree Posterior Augment Pegged Glenoid Integrated Hip System Equinoxe Optetrak Logic Femoral Stem Centralizer Optetrak HiFlex Aysm PS Cemnt Fmrl Optetrak HiFlex PS Tibial Insert Equinoxe Orthopaedic osteotome Porous Coated Curciate Retained Fem Equinoxe Vantage Total Ankle System Optetrak Knee offset Tibial Tray Optetrak Logic CRC Tibial Inserts Optetrak Total Knee Sz 0/1 Delta Novation Crown Cup AcuMatch L-Series Unipolar 12/14 Alumina Femoral Heads 36mm Novation Crown Cup Constrained L&R RESORBABLE ROOM TEM ExactechGPS Optetrak Logic Porous Femoral Component Exactech Bipolar Hip Prosthesis Exactech Equinoxe Reverse Shoulder Orthopaedic Bone file/rasp, manual Novation cemented plus femoral stem Cemented Total Knee Sys Tibial Comp AuRa Hip System Cemented Femrl Stem BIT Logic PSC Tibial Insert 12/14 Total Hip System Alteon Bone Screws Bone curette Equinoxe Small Reverse Shoulder Alteon Tapered Wedge Femoral Stem Exactech Equinoxe Shoulder System Intgrtd Hip Sys M-Sers Fmrl Stm Com Orthopaedic Bone file/rasp, manual M-SERIES ROUND OSTEOTOME EPIC AcuMatch A-Series /MCS Con Ace Linr Truliant CRC tibial insert, size 5, 12mm Truliant CR Slope + tibial insert, size 5, 10mm Truliant CR Slope ++ tibial insert, size 2, 12mm Truliant CRC tibial insert, size 3, 12mm Truliant CR Slope + tibial insert, size 4.5, 10mm Truliant CR Slope + tibial insert, size 1, 10mm Truliant CRC tibial insert, size 4.5, 19mm Truliant PSC tibial insert, size 6, 10mm Truliant CR Neutral tibial insert, size 5, 14mm Truliant PS tibial insert, size 2.5, 12mm Truliant CR Slope + tibial insert, size 4.5, 13mm Truliant CR Neutral tibial insert, size 0, 10mm Truliant CR Neutral tibial insert, size 1, 14mm Truliant PSC tibial insert, size 4, 10mm Truliant CR Slope + tibial insert, size 4.5, 11mm Truliant CRC tibial insert, size 3.5, 10mm Truliant CR Cemented Femoral, size 4.5 Left Truliant CR Slope ++ tibial insert, size 4, 12mm Truliant CR Slope + tibial insert, size 1.5, 10mm Truliant PSC tibial insert, size 3.5, 14mm Truliant CRC tibial insert, size 3, 10mm Truliant CR Slope ++ tibial insert, size 4.5, 12mm Truliant PS tibial insert, size 4.5, 9mm Truliant PS tibial insert, size 4.5, 19mm Truliant PSC tibial insert, size 2.5, 12mm Truliant CR Slope ++ tibial insert, size 4.5, 11mm Truliant PSC tibial insert, size 3.5, 12mm Truliant PSC tibial insert, size 2, 10mm Truliant CR Neutral tibial insert, size 4, 14mm Truliant CRC tibial insert, size 0, 10mm Truliant CR Slope + tibial insert, size 5, 12mm Truliant PS tibial insert, size 1.5, 14mm Truliant PS Cemented Femoral, size 4.5 Left Truliant CRC tibial insert, size 6, 10mm Truliant Fit tibial tray, cemented, size 4.5F/4.5T Truliant CR Neutral tibial insert, size 4.5, 14mm Truliant CR Slope + tibial insert, size 2, 12mm Truliant PS tibial insert, size 3, 14mm Truliant CRC tibial insert, size 2, 12mm Truliant CRC tibial insert, size 2, 14mm Truliant CR Slope + tibial insert, size 4, 10mm Truliant PS tibial insert, size 3.5, 12mm Truliant CRC tibial insert, size 0, 12mm Truliant PSC tibial insert, size 3, 14mm Truliant CR Slope ++ tibial insert, size 4.5, 10mm Truliant PSC tibial insert, size 4.5, 19mm Truliant CRC tibial insert, size 1.5, 12mm Truliant PSC tibial insert, size 4.5, 14mm Truliant CR Slope ++ tibial insert, size 0, 10mm Truliant PSC tibial insert, size 4.5, 15mm Truliant CR Neutral tibial insert, size 0, 12mm Truliant PSC tibial insert, size 2, 12mm Truliant PS Cemented Femoral, size 4.5 Right Truliant CR Slope ++ tibial insert, size 4, 10mm Truliant CRC tibial insert, size 1.5, 14mm Truliant CR Slope ++ tibial insert, size 2.5, 10mm Truliant CRC tibial insert, size 4.5, 12mm Truliant CR Slope ++ tibial insert, size 5, 12mm Truliant PSC tibial insert, size 5, 14mm Truliant CR Neutral tibial insert, size 4.5, 9mm Truliant CRC tibial insert, size 4, 12mm Truliant CRC tibial insert, size 4.5, 14mm Truliant PSC tibial insert, size 3.5, 10mm Truliant CR Neutral tibial insert, size 6, 14mm Truliant CRC tibial insert, size 4.5, 9mm Truliant CR Neutral tibial insert, size 1.5, 10mm Truliant PS tibial insert, size 0, 14mm Truliant CRC tibial insert, size 2.5, 12mm Truliant CRC tibial insert, size 2, 10mm Truliant CR Slope + tibial insert, size 2, 10mm Truliant CR Slope + tibial insert, size 1, 12mm Truliant CR Neutral tibial insert, size 4, 12mm Truliant CR Slope ++ tibial insert, size 3, 10mm Truliant PS tibial insert, size 0, 12mm Truliant PSC tibial insert, size 0, 10mm Truliant CR Slope + tibial insert, size 1.5, 12mm Truliant CR Neutral tibial insert, size 4.5, 10mm Truliant CR Neutral tibial insert, size 1.5, 12mm Truliant CRC tibial insert, size 2.5, 14mm Truliant CR Neutral tibial insert, size 3.5, 14mm Truliant PS tibial insert, size 3, 10mm Truliant CRC tibial insert, size 6, 12mm Truliant CRC tibial insert, size 0, 14mm Truliant Fit tibial tray, cemented, size 4.5F/5.5T Truliant CR Slope + tibial insert, size 4.5, 9mm Truliant CR Slope ++ tibial insert, size 1.5, 12mm Truliant PSC tibial insert, size 6, 14mm Truliant PSC tibial insert, size 4.5, 9mm Truliant PS tibial insert, size 2, 12mm Truliant CR Neutral tibial insert, size 2, 10mm Truliant CRC tibial insert, size 3.5, 14mm Truliant PS tibial insert, size 3.5, 14mm Truliant CRC tibial insert, size 4.5, 17mm Truliant CR Neutral tibial insert, size 0, 14mm Truliant PS tibial insert, size 6, 12mm Truliant CRC tibial insert, size 2.5, 10mm Truliant PSC tibial insert, size 4.5, 11mm Truliant PS tibial insert, size 0, 10mm Truliant CR Slope + tibial insert, size 4, 12mm Truliant CR Neutral tibial insert, size 5, 10mm Truliant CRC tibial insert, size 4, 10mm Truliant CR Neutral tibial insert, size 3.5, 12mm Truliant CR Neutral tibial insert, size 1, 12mm Truliant CRC tibial insert, size 4.5, 11mm Truliant CR Slope + tibial insert, size 0, 12mm Truliant PS tibial insert, size 2, 14mm Truliant CR Slope ++ tibial insert, size 1, 10mm Truliant PS tibial insert, size 4.5, 15mm Truliant PSC tibial insert, size 5, 10mm Truliant CR Slope ++ tibial insert, size 5, 10mm Truliant CR Neutral tibial insert, size 2, 12mm Truliant CR Slope + tibial insert, size 2.5, 10mm Truliant CRC tibial insert, size 5, 14mm Truliant PS tibial insert, size 5, 10mm Truliant CR Slope ++ tibial insert, size 3.5, 10mm Truliant PSC tibial insert, size 2.5, 14mm Truliant CRC tibial insert, size 5, 10mm Truliant PSC tibial insert, size 3, 12mm Truliant CR Neutral tibial insert, size 2.5, 10mm Truliant CR Neutral tibial insert, size 4.5, 11mm Truliant PS tibial insert, size 2.5, 14mm Truliant CR Slope + tibial insert, size 6, 12mm Truliant CR Neutral tibial insert, size 1.5, 14mm Truliant PS tibial insert, size 4, 14mm Truliant PSC tibial insert, size 1, 10mm Truliant PSC tibial insert, size 1, 12mm Truliant PS tibial insert, size 1.5, 12mm Truliant CRC tibial insert, size 4.5, 13mm Truliant CR Slope + tibial insert, size 4.5, 12mm Truliant PS tibial insert, size 4.5, 14mm Truliant PSC tibial insert, size 4.5, 17mm Truliant CR Neutral tibial insert, size 2.5, 14mm Truliant PS tibial insert, size 4.5, 11mm Truliant CR Slope ++ tibial insert, size 2, 10mm Truliant PSC tibial insert, size 4.5, 13mm Truliant PSC tibial insert, size 0, 14mm Truliant CR Slope + tibial insert, size 3, 12mm Truliant CRC tibial insert, size 3.5, 12mm Truliant PS tibial insert, size 1, 14mm Truliant PSC tibial insert, size 3, 10mm Truliant CR Slope + tibial insert, size 2.5, 12mm Truliant PS tibial insert, size 2.5, 10mm Truliant CR Neutral tibial insert, size 2.5, 12mm Truliant CRC tibial insert, size 4, 14mm Truliant CRC tibial insert, size 4.5, 10mm Truliant CRC tibial insert, size 1.5, 10mm Truliant CRC tibial insert, size 3, 14mm Truliant PS tibial insert, size 5, 12mm Truliant CR Neutral tibial insert, size 4.5, 15mm Truliant CR Neutral tibial insert, size 4.5, 17mm Truliant CR Neutral tibial insert, size 4, 10mm Truliant CRC tibial insert, size 1, 10mm Truliant PS tibial insert, size 1, 10mm Truliant PSC tibial insert, size 4, 12mm Truliant PS tibial insert, size 6, 14mm Truliant CR Neutral tibial insert, size 3, 14mm Truliant CR Neutral tibial insert, size 1, 10mm Truliant CR Neutral tibial insert, size 3, 10mm Truliant PSC tibial insert, size 5, 12mm Truliant CR Neutral tibial insert, size 4.5, 12mm Truliant Fit tibial tray, cemented, size 4.5F/3.5T Truliant CR Slope ++ tibial insert, size 3, 12mm Truliant CR Slope + tibial insert, size 3.5, 12mm Truliant PSC tibial insert, size 1, 14mm Truliant PS tibial insert, size 6, 10mm Truliant CR Slope ++ tibial insert, size 0, 12mm Truliant PS tibial insert, size 1, 12mm Truliant CR Neutral tibial insert, size 3, 12mm Truliant PS tibial insert, size 4, 10mm Truliant CR Slope + tibial insert, size 3.5, 10mm Truliant CR Neutral tibial insert, size 4.5, 13mm Truliant PSC tibial insert, size 4.5, 12mm Truliant CR Slope ++ tibial insert, size 4.5, 9mm Truliant PSC tibial insert, size 2, 14mm Truliant PS tibial insert, size 4.5, 13mm Truliant CR Slope ++ tibial insert, size 1, 12mm Truliant CRC tibial insert, size 4.5, 15mm Truliant CR Slope ++ tibial insert, size 6, 12mm Truliant CR Slope ++ tibial insert, size 1.5, 10mm Truliant PSC tibial insert, size 2.5, 10mm Truliant PS tibial insert, size 3, 12mm Truliant CR Slope + tibial insert, size 3, 10mm Truliant PSC tibial insert, size 4, 14mm Truliant PSC tibial insert, size 1.5, 10mm Truliant PS tibial insert, size 5, 14mm Truliant PS tibial insert, size 4.5, 17mm Truliant PS tibial insert, size 4, 12mm Truliant CRC tibial insert, size 6, 14mm Truliant PSC tibial insert, size 6, 12mm Truliant PSC tibial insert, size 1.5, 12mm Truliant PS tibial insert, size 4.5, 12mm Truliant PS tibial insert, size 4.5, 10mm Truliant CR Neutral tibial insert, size 3.5, 10mm Truliant CR Slope ++ tibial insert, size 2.5, 12mm Truliant CR Neutral tibial insert, size 5, 12mm Truliant CR Slope ++ tibial insert, size 3.5, 12mm Truliant CR Neutral tibial insert, size 6, 10mm Truliant CR Slope + tibial insert, size 0, 10mm Truliant CR Neutral tibial insert, size 2, 14mm Truliant PSC tibial insert, size 0, 12mm Truliant PSC tibial insert, size 4.5, 10mm Truliant CR Cemented Femoral, size 4.5 Right Truliant CR Slope ++ tibial insert, size 4.5, 13mm Truliant PS tibial insert, size 1.5, 10mm Truliant CRC tibial insert, size 1, 14mm Truliant CRC tibial insert, size 1, 12mm Truliant PSC tibial insert, size 1.5, 14mm Truliant CR Neutral tibial insert, size 6, 12mm Truliant PS tibial insert, size 2, 10mm Truliant PS tibial insert, size 3.5, 10mm Alteon Alteon Neck Preserving Femoral Stem DEPTH Optetrak Logic CR Equinoxe Reverse +15mm Adapter Tray Novation Splined RDD Femoral Stems Optecure+CCC Optecure Optetrak Total Knee System Equinoxe Optetrak Logic Porous Femoral Components AcuMatch MSeries LPB 12/14 Femoral Exactech Optetrak Logic Metaphyseal Cones Alteon TRULIANT Porous Tibial Tray Ziramic Zirconia 12/14 Femoral Head Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies AcuMatch MSeries Offset Neck Sgmnts Optetrak Logic Fit Tray Optetrak Logic Combo Tibial Tray

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2011-10-05
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2011-10-05
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2011-10-05
HWT	Template	Orthopedic	Class 1	888.4800	1992-07-15
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1992-07-15
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2022-06-16
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2015-09-08
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2002-10-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-05-28
HTQ	Broach	Orthopedic	Class 1	888.4540	1992-07-15
KDG	Chisel (Osteotome)	General, Plastic Surgery	Class 1	878.4820	2022-06-16
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2024-11-06
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2024-11-06
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2008-01-10
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2008-01-10
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2008-01-10
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2008-01-10
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2019-05-06
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-03-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-03-20
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2008-01-15
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2008-01-15
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2002-10-22
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2017-02-27
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2008-01-10
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2008-01-10
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2008-01-10
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2008-01-10
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2008-01-10
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2024-08-09
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2024-08-09
HWB	Extractor	Orthopedic	Class 1	888.4540	1992-07-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2011-06-23
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2008-01-14
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2017-02-13
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2017-02-13
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2017-02-13
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2017-02-13
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2006-09-25
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2010-09-28
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2010-09-28
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2010-09-28
PKC	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Orthopedic	Class 2	888.3660	2020-06-10
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2002-10-22
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2016-09-28
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2008-07-29
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-11-26
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2014-05-05
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2021-11-03
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2008-01-15
PKC	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Orthopedic	Class 2	888.3660	2018-03-13
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-05-28
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2015-10-05
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2007-12-10
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2008-01-14
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2008-03-31
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2008-03-31
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2008-03-31
HXC	Wrench	Orthopedic	Class 1	888.4540	2022-06-16
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2015-10-05
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2015-10-05
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2015-10-05
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2015-10-05
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2015-10-05
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-05-28
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2011-10-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-02-05
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2015-09-21
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2015-06-01
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2008-01-14
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2012-01-09
NTG	Prosthesis, Ankle, Uncemented, Non-Constrained	Unknown	Class 3	N/A	2019-10-07
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-06-21
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2013-06-21
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-06-21
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-06-21
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2013-06-21
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2008-01-14
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-03-13
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2018-03-13
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Orthopedic	Class 2	888.3353	2018-03-13
HRT	Stripper, Surgical	Orthopedic	Class 1	888.4540	2022-06-16
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2013-11-13
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2013-11-13
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2013-06-20
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2022-07-22
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2013-06-21
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2008-01-14
HWA	Impactor	Orthopedic	Class 1	888.4540	2002-10-22
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2011-10-05
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2011-10-05
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2011-10-05
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2011-10-05
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2008-01-15
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2008-01-15
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2008-01-15
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2008-01-15
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2008-01-15
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2008-01-11
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2008-01-11
HXG	Tamp	Orthopedic	Class 1	888.4540	2002-10-22
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2008-01-14
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2008-01-14
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2011-06-23
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2011-10-05
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2011-10-05
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2011-10-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-05-28
NUN	Bone Grafting Material, Human Source	Dental	Class 2	872.3930	2011-10-05
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2013-06-21
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-06-21
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-06-21
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2026-05-20
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2004-03-22
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2004-03-22
HWD	Starter, Bone Screw	Orthopedic	Class 1	888.4540	2022-03-23
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2011-04-12
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2011-04-12
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2011-04-12
HXY	Brace, Drill	Orthopedic	Class 1	888.4540	1992-07-15
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2013-04-18
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2008-01-14
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2008-01-14
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2010-09-28
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2010-09-28
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-11-13
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2008-01-14
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2008-01-14
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2019-10-07
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2019-10-07
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2019-10-07
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2022-06-16
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2008-01-15
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2011-07-29
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2011-07-29
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2016-04-18
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2008-01-14
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-06-21
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2008-01-14
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2010-12-14
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2010-12-14
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2010-12-14
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2010-12-14
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2010-12-14
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2008-01-10
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2008-01-11
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2008-01-15
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2004-03-22
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2004-03-22
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2025-07-28
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2014-08-04
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-08-04
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2007-12-10
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2010-06-04
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2010-06-04
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2010-06-04
HTP	File	Orthopedic	Class 1	888.4540	2022-06-16
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2008-12-18
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2008-12-18
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2008-01-14
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2008-01-14
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	1992-07-15
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2011-10-05
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2008-01-14
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2008-01-14
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2008-01-14
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2008-01-14
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2008-01-14
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2014-08-01
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-06-16
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2018-07-26
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2018-07-26
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2018-07-26
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2014-10-13
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2014-10-13
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2014-10-13
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2014-10-13
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2014-10-13
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2014-10-13
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2014-10-13
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2008-01-10
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2008-01-10
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2008-01-14
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2008-01-14
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2022-06-16
HWP	Punch, Femoral Neck	Orthopedic	Class 1	888.4540	2002-10-22
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-05-28
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2008-01-10
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2017-05-03
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2014-10-13
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2014-10-13
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2014-10-13
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	1992-07-15
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2012-06-04
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2008-12-16
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2008-12-16
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2008-12-16
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2008-01-15
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2008-01-15
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2008-01-15
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2008-01-15
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2017-04-26
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2017-04-26
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2008-01-14
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2023-10-11
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2023-10-11
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2023-10-11
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-06-21
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2008-01-15
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2008-01-15
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2008-01-15
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2016-03-25
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2015-10-05
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2018-10-16
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2018-10-16
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2018-10-16
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2019-02-15
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2019-02-15
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2008-01-11
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2008-01-11
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2017-04-03
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2017-04-03
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2017-04-03
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2017-04-03
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2008-01-14
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2011-10-05

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EXACTECH, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

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Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008658204	Exactech Sarasota	Sarasota, FL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K904879	Endotec, Inc.	BEUCHEL-PAPPAS GLENOID COMPONENT	1991-01-28
K141345	Tornier S.A.S.	AEQUALIS FX2	2014-11-18
K901338	Kirschner Medical Corp.	KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM	1990-05-22
K030577	Stelkast Company	PROVEN MODULAR TIBIAL TRAY	2003-03-25
K153310	Total Joint Orthopedics, Inc.	Klassic Knee System	2015-12-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2019	Exactech, Inc.	2	Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
Z-0019-2022	Exactech, Inc.	2	OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product Line Numbers: 204-11-XX, 204-12-XX, 204-13-XX, 204-14-XX, 204-15-XX, 204-16-XX; c. OPTETRAK HI-FLEX PS Polyethylene Tibial Inserts, with Product Line Numbers: 244-20-XX, 244-21-XX, 244-22-XX, 244-23-XX, 244-24-XX, 244-25-XX; d. OPTETRAK CR Tibial Inserts, with Product Line Numbers: 200-21-XX, 200-22-XX, 200-23-XX, 200-24-XX, 200-25-XX, 200-26-XX, 200-50-XX, 200-51-XX; e. OPTETRAK CR Tibial Slope + Insert, with Product Line Numbers: 200-56-XX, 200-57-XX, 200-61-XX, 200-62-XX, 200-63-XX, 200-64-XX, 200-65-XX; f. OPTETRAK CR Tibial Slope ++ Insert, with Product Line Numbers: 200-57-XX, 200-71-XX, 200-72-XX, 200-73-XX, 200-74-XX, 200-75-XX; g. OPTETRAK PS Tibial Inserts, with Product Line Numbers: 204-21-XX, 204-22-XX 204-23-XX, 204-24-XX, 204-25-XX, 204-26-XX, 204-50-XX, 204-51-XX; h. OPTETRAK "MOMB" Non-Mod Molded Insert, with Product Line Numbers: 204-91-XX, 204-92-XX, 204-93-XX, 204-94-XX, 204-95-XX; i. OPTETRAK CC Tibial Insert, with Product Line Numbers: 208-21-XX, 208-22-XX, 208-23-XX, 208-24-XX, 208-25-XX, 208-51-XX; j. OPTETRAK B-Series PS Tibial Insert, with Product Line Numbers: 224-21-XX, 224-22-XX, 224-23-XX, 224-24-XX. Affected 510(k) numbers include: K932690, K933494, K932776, K011976, K082022, K933610, K030686, K954208, K010434, K033883. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Z-0020-2022	Exactech, Inc.	2	OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Z-0021-2022	Exactech, Inc.	2	OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Z-0022-2022	Exactech, Inc.	2	OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 900-08-XX); b. CUSTOM OPTETRAK CC TIBIAL INSERT (Product Line: 900-23-XX, 900-30-XX); c. CUSTOM OPTETRAK CC INSERT (Product Line: 900-33-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Z-0023-2022	Exactech, Inc.	2	TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Z-0024-2022	Exactech, Inc.	2	Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Z-0025-2022	Exactech, Inc.	2	OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Z-0026-2022	Exactech, Inc.	2	OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Z-0027-2022	Exactech, Inc.	2	ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1038671. Last updated year: 2026. Please use registration number 1038671 when referencing this establishment in official correspondence.