Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1834331

FEI Number

1000306340

Entity Name

PARAGON MEDICAL, INC.

City/State/Country

PIERCETON, IN, US

Establishment Address

8 Matchett Dr., PIERCETON, IN 46562, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Paragon Medical (Owner Number: 9011072)

Owner / Operator Contact Address

8 Matchett Dr., --, Pierceton, IN 46562, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GALAXY WRIST TRAY EMPTY TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER ANKLE HINDFOOT NAILING SYSTEM - INSERTION INSTRUMENTS CASE EMPTY ANKLE HINDFOOT NAILING SYSTEM - DRILLS AND REAMERS CASE EMPTY ANKLE HINDFOOT NAILING SYSTEM - EXTRACTION INSTRUMENTS CASE EMPTY Zimmer Nexel Total Elbow REAMER DEPTH STOP 10/12MM GENESIS The GIRO Growth Modulation System Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe) REAMER DEPTH STOP 8/10MM Z1 Hip System A.L.P.S. Clavicle Plating System Clavicle Plating Instruments ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology Camera Sterilization Tray Set Endoscope and Camera Sterilization Tray Set Advanced Imaging Modality (AIM) Sterilization Tray Set Sonopet iQ Sterilization Tray Comp. Primary Broach Cover Set TRUELOK TRAUMA - INSTRUMENTS CASE, US TRUELOK TRAUMA CASE, US TriALTIS Spine System Zimmer Biomet Fluted Pin Various Drills for Foot Surgery (Twist Drill, Over-Drill, Drill Bit) Universal Pin SYNERGY Comprehensive Shoulder System Driver STERILIZATION BOX EMPTY EXPEDIUM VERSE DRIVER - SLEEVE TriALTIS Navigation Enabled Instruments Comprehensive SRS Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented. Shoulder Prosthesis, Reverse Configuration Comprehensive Revision Broach/Provisional 12mm Comprehensive Revision Broach/Provisional 8mm Comprehensive Revision Broach/Provisional 14mm Comprehensive Revision Broach/Provisional 6mm Comprehensive Revision Broach/Provisional 10mm Comprehensive Revision Broach/Provisional 4mm Comprehensive Shoulder System Zimmer Persona Personalized Knee System PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER Persona® The Personalized Knee System Persona Revision Knee System Zimmer Biomet TRIGEN POLYETHYLENE LINER EXTRACTOR DRIVE SHAFT TRABECULAR METAL REVISION SHELL LINERS Drill Sleeve Insert K-Wire Sleeve Insert Orthopedic Manual Surgical Instrument LITe Funnel Bone Tap Freehand Drill IMN Instruments ø4.2x185mm Locking Drill IMN Instruments ø4.2x360mm Trocar SPS-MonoAxial Locking Set 5mm Inserter sleeve Freehand Drill IMN Instruments ø3.5x130mm Drill Sleeve D4.3 "Insertion Sleeve for ø3.2mm Guide Wires" Depth Gauge 0-120mm Insert ø3.2 compression Guide Wire D3xL300 Trocar SPS-MonoAxial Locking Set 4mm Freehand Drill IMN Instruments ø3.5x185mm Zimmer Biomet Drill Guide ø6.55 Drilling Guide ø3.2/4.5 Locking Drill IMN Instruments ø3.5x360mm Depth Gauge 0-70mm for Screws: ø2.7/3.5/4mm Freehand Drill IMN Instruments ø4.2x130mm Insert ø2.5 compression Tissue prot. sleeve ø6.5/4.5 Threaded Guide Wire D3.2xL300 (Sterile) Screw Insertion Sleeve ø9mm Lag Screw Tap Sleeve Drilling Guide ø2.5/3.5 Parallel Drill Guide Insert ø2.5 neutral Drill Sleeve Handle Direct Measuring Gauge Depth Gauge 0-150mm for Screws: ø4.5/6.5mm Drill Guide Supracondylar Lag Screw Depth Gauge Drill Sleeve D3.1 Depth Gauge 0-110mm For Screws ø2.7/3.5/4 Depth Gauge 0-150mm for Screws: ø2.7/3.5/4mm Insert ø2.5 support Drilling Guide ø2/2.7 Drill Gauge (Percutaneous) Guide Wire D3.2xL300 Threaded Guide Wire D3.2xL300 Guide Wire with Ruler Tube Insert ø3.2 neutral Guide Wire D3.2xL300 (Sterile) Distractor Twist Drill Centerpiece Plate Fixation System C-STEM AMT SZ 3A NK SEGMENT IMN Instruments C-STEM AMT STD NECK SEGMENT- SZ0/1 INSERTION SHIM - HANDLE Guide Wire C-STEM AMT SZ 2A NK SEGMENT C-STEM AMT HO NECK SEGMENT- SZ4/5 C-STEM AMT HO NECK SEGMENT- SZ 0/1 C-STEM AMT HO NECK SEGMENT- SZ2/3 C-STEM AMT STD NECK SEGMENT- SZ2/3 C-STEM AMT STD NECK SEGMENT- SZ6/7 AMBI Zimmer Biomet TRABECULAR METAL REVISION SHELL LINERS Robotic Integration Instruments Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Tornier HRS Max Two Level Rack Stryker Universal Select Sterilization Tray System STERILIZATION BOX EMPTY EXTENDED PLUS LINE CADDY EMPTY QUAD PLATE PLUS CADDY EMPTY EIGHT PLATE PLUS CADDY EMPTY TriALTIS Navigation Enabled Instruments Graft Sizer SharpShooter Cannula Right Middle SharpShooter Cannula Right Posterior CMI Delivery Clamp CMI Measuring Cannula SharpShooter Cannula Left Middle SharpShooter Cannula Right Anterior SharpShooter Cannula Left Anterior SharpShooter Cannula Left Posterior Intermediate Zimmer Biomet Tap, Locking, AO 2 FRAGMENT PLATE BENDER END 2 FRAGMENT PLATE BENDER Depth Gage Tornier HRS Max SYMPHONY INSTRUMENT GRAPHIC CASE KEEL TIB PUNCH GUIDE SZ1.5-4 Tornier HRS Max TriALTIS Spine System TriALTIS Navigation Enabled Instruments EXPEDIUM VERSE DRIVER - SLEEVE 36MM POLY LINER PLUS 3MM OFS C-STEM AMT BROACH SIZE 3 C-STEM AMT BROACH SIZE 2 C-STEM AMT BROACH SIZE 1A C-STEM AMT BROACH SIZE 3A C-STEM AMT BROACH SIZE 1 C-STEM AMT BROACH SIZE 2A C-STEM AMT BROACH SIZE 8 C-STEM AMT BROACH SIZE 5 C-STEM AMT BROACH SIZE 7 C-STEM AMT BROACH SIZE 4 AGILE NAIL STERILIZATION BOX EMPTY AGILE NAIL STERILIZATION BOX EXTRACTION EMPTY Zimmer Persona Personalized Knee System Persona® The Personalized Knee System Persona® The Personalized Knee System PERSONA NATURAL TIBIA BASEPLATES Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-12-18
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2015-12-14
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2016-01-13
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2015-12-14
JDC	Prosthesis, Elbow, Constrained, Cemented	Orthopedic	Class 2	888.3150	2018-06-21
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2022-05-11
HTO	Reamer	Orthopedic	Class 1	888.4540	2013-01-17
LYS	Bone Mill	Orthopedic	Class 1	888.4540	2024-09-13
HTQ	Broach	Orthopedic	Class 1	888.4540	2013-01-17
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2013-01-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-18
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-18
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-18
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-01-17
KFK	Saw, Pneumatically Powered	General, Plastic Surgery	Class 1	878.4820	2013-01-18
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2016-01-13
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Orthopedic	Class 2	888.3170	2016-03-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-02-05
NDL	Pin, Fixation, Smooth, Metallic	Orthopedic	Class 2	888.3040	2026-02-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-02-05
NDL	Pin, Fixation, Smooth, Metallic	Orthopedic	Class 2	888.3040	2026-02-05
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2024-02-23
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2024-02-23
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2016-01-11
NJL	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing	Unknown	Class 3	N/A	2016-07-18
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-17
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-17
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2019-06-24
HXC	Wrench	Orthopedic	Class 1	888.4540	2016-12-13
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-03-16
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2020-01-15
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2016-01-13
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2013-01-17
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2013-01-17
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2025-07-11
LXT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	Orthopedic	Class 2	888.3030	2015-12-14
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-11-10
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-02-04
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2013-02-04
HXG	Tamp	Orthopedic	Class 1	888.4540	2013-01-30
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2013-12-11
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2013-01-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2016-03-16
JDJ	Mesh, Surgical, Acetabular, Hip, Prosthesis	General, Plastic Surgery	Class 2	878.3300	2020-06-15
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2020-06-15
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2020-06-15
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2020-06-15
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2020-06-15
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2020-06-15
JDG	Prosthesis, Hip, Femoral Component, Cemented, Metal	Orthopedic	Class 2	888.3360	2020-06-15
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2020-06-15
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2020-06-15
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2020-06-15
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2020-06-15
LZY	Prosthesis, Hip, Hemi-, Femoral, Metal Ball	Orthopedic	Class 2	888.3360	2020-06-15
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2020-06-15
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2022-03-24
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2022-03-24
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2022-03-24
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2022-03-24
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2018-01-29
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2016-01-13
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2013-01-20
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2016-01-13
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2017-11-22
KXE	Prosthesis, Wrist, Hemi-, Ulnar	Orthopedic	Class 2	888.3810	2016-03-16
HWJ	Awl	Orthopedic	Class 1	888.4540	2008-10-14
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2014-01-10
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-01-10
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-09-13
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2020-01-16
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2020-01-16
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2020-01-16
JDC	Prosthesis, Elbow, Constrained, Cemented	Orthopedic	Class 2	888.3150	2020-01-16
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2016-01-20
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2016-01-20
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2025-03-21
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3660	2025-03-21
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2025-03-21
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2025-03-21
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2025-03-21
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2025-03-21
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-18
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-18
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2020-01-15
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2020-01-15
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2020-01-15
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2020-01-15
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-11-06
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2018-11-06
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2018-11-06
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2024-12-18
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2016-03-16
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2013-02-06
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2022-09-07
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3660	2022-09-07
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2022-09-07
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-10-24
MAY	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	Orthopedic	Class 2	888.3353	2013-10-24
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2013-10-24
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2013-10-24
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-10-24
HWB	Extractor	Orthopedic	Class 1	888.4540	2013-01-30
MMO	Tray, Surgical, Ent	Ear, Nose, Throat	Class 1	874.4420	2013-01-18
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2016-01-13
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2025-05-09
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3660	2025-05-09
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2025-05-09
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2025-05-09
PKC	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Orthopedic	Class 2	888.3660	2025-05-09
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2013-01-30
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2007-12-28
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2013-04-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-02-05
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-01-17
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2016-10-31
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2016-10-31
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2025-06-12
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-06-12
MPK	Semi-Constrained Metal/Polymer Finger Joint Prosthesis	Unknown	Class f	N/A	2016-03-16
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-12-03
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2019-11-11
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2019-11-11
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2019-11-11
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2013-01-30
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2018-04-20
OBT	Plate, Bone, Growth Control, Pediatric, Epiphysiodesis	Orthopedic	Class 2	888.3030	2018-11-09
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-18
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-11-10
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2013-01-30
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-01-18
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2013-01-18
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2016-03-16
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2013-01-17
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2013-01-30
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2013-01-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-17
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2019-05-07
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2013-01-17
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-12-18
KWG	Prosthesis, Finger, Constrained, Metal/Polymer	Orthopedic	Class 3	888.3220	2016-03-16
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2024-12-18
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2021-07-07
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-17
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2013-01-17
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Orthopedic	Class 2	888.3170	2016-03-16
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2015-11-10
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2015-11-10
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2015-11-10
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2015-11-10
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-01-17
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-01-17
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-06-02
HWT	Template	Orthopedic	Class 1	888.4800	2013-01-20
NPJ	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-01-18
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3540	2013-01-18
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2013-01-18
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-11-19
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2025-11-19
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-11-19
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-11-19
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-01-18
KYJ	Prosthesis, Finger, Constrained, Polymer	Orthopedic	Class 2	888.3230	2016-03-16
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-12-18
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2016-01-13
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2016-01-13
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2016-01-13
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2016-01-28
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2016-01-28
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3660	2016-01-28
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2016-01-28
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2016-10-10
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3660	2022-05-11
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2022-05-11
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2022-05-11
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2022-05-11
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2022-05-11
QBO	Instruments Designed For Press-Fit Osteochondral Implants	Orthopedic	Class 2	888.4505	2022-07-29
KXE	Prosthesis, Wrist, Hemi-, Ulnar	Orthopedic	Class 2	888.3810	2016-03-16
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-17
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-01-17
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-01-17
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2016-01-13
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2016-01-13
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2016-01-13
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2008-10-14
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-01-17
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2013-01-18
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2013-01-18
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2013-01-18
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2013-01-18
HBB	Motor, Drill, Pneumatic	Neurology	Class 2	882.4370	2013-01-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2016-03-16
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2018-11-09
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2020-12-16
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2020-12-16
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2020-12-16
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2019-11-11
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2019-11-11
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2019-11-11
JDB	Prosthesis, Elbow, Semi-Constrained, Cemented	Orthopedic	Class 2	888.3160	2016-03-16
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-01-18

Official Correspondent

Stephane Langlois

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Paragon Medical

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009141957	AMETEK Poland sp. z o.o.	Siechnice Dolnoslaskie, PL
3007539489	Paragon Medical Device (Changzhou) Co., Ltd.	Changzhou Jiangsu, CN
1835831	Paragon Medical Inc.	Castleton, IN, US
1000517406	Paragon Medical Inc.	Smithfield, UT, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26
K033476	Howmedica Osteonics Corp.	MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM	2004-01-20
K040336	Synthes (Usa)	SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM	2004-04-12
K083648	Efratgo, Ltd. HI Tech Bio-Surgical	GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL	2009-05-14
K192312	Zimmer GmbH	Zimmer Natural Nail System Cephalomedullary Nails	2019-10-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0032-2009	Biomet, Inc.	2	Biomet brand Discovery Elbow, 3 mm x 75 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114813. The product intended use is for Orthopedic implant.
Z-0033-2009	Biomet, Inc.	2	Biomet brand Discovery Elbow, 3 mm x 115 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114817. The product intended use is for Orthopedic implant.
Z-0021-2015	Biomet, Inc.	1	Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Z-0026-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S

Similar Registrations

Registration Number	Establishment Name	Location
3002743211	NORTHERN DIGITAL, INC.	WATERLOO Ontario, CA
3016050940	Olive Branch Distribution Center	Olive Branch, MS, US
3020983478	ORTHOKEY ITALIA SRL	Firenze, IT
3014725904	Medtronic Medical Costa Rica S.R.L.	Coyol Alajuela, CR
3018405359	A7 INTEGRATION	Granby Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1834331. Last updated year: 2026. Please use registration number 1834331 when referencing this establishment in official correspondence.