Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007923096

FEI Number

3007923096

Entity Name

Changzhou Biomet Medical Devices Co., Ltd.

City/State/Country

Changzhou City Jiangsu, CN

Establishment Address

No. 235 Chuangxin Road, EPZ Xinbei District, Changzhou City Jiangsu 213031, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Biomet, Inc. (Owner Number: 1825034)

Owner / Operator Contact Address

56 East Bell Dr., PO Box 587, Warsaw, IN 46582, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ANATOMIC LOCKING PLATING SYSTEM ALTRA PRESS-FIT HIP SYSTEM 2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110- 131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424 COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE LORENZ PECTUS SUPPORT BAR, TITANIUM LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM Affixus Tibial Nailing System SYSTEM STERNAL CLOSURE BIOMET MICROFIXATION G7 FINNED ACETABULAR SHELL C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM VANGUARD XP KNEE SYSTEM ACE CANNULATED CORTICAL BONE SCREW ACE 8MM CANNULATED CANCELLOUS BONE SCREW NEXT GENERATION KNEE SYSTEM MAXIM ACCEL KNEE SYSTEM POLARIS SPINAL SYSTEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER LORENZ 1MM, 1.5MM, 2MM SYSTEM MALLORY/HEAD TOTAL HIP SYSTEM LORENZ IMF SCREW NEXTGEN ALTIUS OCT SYSTEM MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTS Biomet Microfixation OmniMax MMF System Z1 Cemented Hip System SUPPORT BAR LORENZ PECTUS STABILIZER Biomet Proximal Humerus Plating System A. L. P. S. Clavicle Plating System SUPPORT BAR LORENZ PECTUS VANGUARD 360 REVISION KNEE SYSTEM MODIFICATION TO ALTIUS OCT SYSTEM MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS FENNING FEMORAL COMPONENT BIOMET MICROFIXATION NEURO PLATING SYSTEM BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM OXFORD MENISCAL UNICOM RAPIDFIRE SELF DRILLING SCREWS SPIN DOWN RAPIDFLAP ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM TRILOGY ACETABULAR SYSTEM POLARIS SPINAL SYSTEM TAPERLOC COMPLETE, SIZE 5 AND 6 APF POROUS COATED LINE EXTENSION Zimmer Persona Personalized Knee System Biomet Microfixation RibFix Blu Thoracic Fixation System Biomet Knee Joint Replacement Prostheses TAPERLOC COMPLETE ACE SUPRACONDYLAR PLATE BIOMET BIPOLAR PROSTHESIS Comprehensive® Reverse Shoulder FINE GRAIN CAST COBALT CHROMIUM HIP STEMS Biomet Microfixation RibFix Blu Thoracic Fixation System ARCPM 1050 RESIN-HIPS OFFSET TIBIAL TRAY Biomet Microfixation SternaLock 360 Sternal Closure System PLATES SYSTEMS MANDIBULAR FRACTURE AND PREBENT BIOMET MICROFIXATION RECONSTRUCTION DEVICES BIOMET TEMPLATE RECOVERY PROTRUSIO CAGE G7 FREEDOM AND OFFSET LINERS, FREEDOM HEAD, SIZE 32 BIOMET MICROFIXATION FACIAL PLATING SYSTEM VERSA-DIAL HUMERAL HEAD PROSTHESIS DEPUY FRACTURE AND FUSION PLATING SYSTEM Biomet Microfixation OmniMax MMF System BIMETRIC COCR HEAD/NECK REPLACEMENT HIP STEM DVR LATERAL PLATE DVR ULNA PLATE DVR DORSAL PLATE DORSAL NAIL PLATE, ANATOMICAL 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S BIPOLAR HIP DEVICE MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM EBI 5.5 Helical Flange Spinal System DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM ACE CANCELLOUS BONE SCREW MODIFIED DISTAL RADIUS PLATING SYSTEM AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN 150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISH ACE 3.5MM CORTICAL BONE SCREW MICROPLASTY TIBIAL TRAYS RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS 130 MODIFIED INTEGRAL FEMORAL COMPONENT LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSIO PLATE, MODEL 824077010, COMPRESSION FUSION PLATE, RINGLOC BI-POLAR ACETABULAR COMPONENT ACE CANCELLOUS BONE SCREW Affixus Tibial and Antegrade Femoral Nailing System CONTRAINDICATIONS BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED Taperloc Complete Hip Stem COMPREHENSIVE REVERSE SHOULDER FRAGMENT PLATE SYSTEM PROFILE AND MULTIDIRECTIONAL SCREWS PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW Taperloc® Complete Hip Stems 2.5MM INLINE FUSION PLATE TAPERLOC COMPLETE SIZE 4MM & XR 123 INTEGRAL CO-CR FEMORAL COMPONENT LORENZ IMF SCREW SELF-DRILLING POSTERIOR LATERAL PLATES SMALL FRAGMENT LOCKING PLATING SYSTEM TAPERLOC COMPLETE MICROPLASTY STEM Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate NexGen Legacy CCK (L-CCK) NexGen Legacy PS (L-PS) Comprehensive Shoulder System Biomet Microfixation RibFix Blu Thoracic Fixation System DISTAL RADIUS VOLAR RIM PLATE STANDARD AND NARROW Comprehensive Vault Reconstruction System Biomet Microfixation Thoracic Fixation System SMALL BONE LOCKING PLATING SYSTEM ACE CANNULATED SELF-TAPPING CORTICAL BONE SCREW 6.5MM SOLID CANCELLOUS BONE SCREW DISTAL VOLAR RADIUS PLATING SYSTEMS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-06-18
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2012-06-18
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-06-18
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2008-02-05
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2008-02-05
MAY	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	Orthopedic	Class 2	888.3353	2008-02-05
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2008-02-05
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2008-02-05
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Orthopedic	Class 3	888.3330	2008-02-05
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2008-02-05
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2008-02-05
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2008-02-05
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2008-02-05
JDL	Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)	Orthopedic	Class 3	888.3320	2008-02-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-06-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-06-18
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2012-11-27
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2012-11-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-01-13
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2016-05-04
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2016-05-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-01-13
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2015-01-05
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Orthopedic	Class 2	888.3353	2015-01-05
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2015-01-05
PBI	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive	Orthopedic	Class 2	888.3310	2015-01-05
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2015-01-05
OQH	Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3350	2015-01-05
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2015-01-05
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2015-01-05
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2011-05-05
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2014-05-06
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-05-06
MBV	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-05-06
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2014-05-06
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-06-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-06-18
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2015-12-29
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2008-02-13
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-05-01
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-05-01
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-05-01
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-05-01
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-05-01
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2015-01-07
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2015-01-07
MBV	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2015-01-07
JEY	Plate, Bone	Dental	Class 2	872.4760	2014-01-13
KMC	Prosthesis, Hip, Semi-Constrained, Composite/Metal	Orthopedic	Class 2	888.3340	2012-11-14
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2014-01-13
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-06-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-06-28
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-06-28
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2018-11-05
JEY	Plate, Bone	Dental	Class 2	872.4760	2019-02-16
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2019-02-16
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2025-07-21
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2025-07-21
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2025-07-21
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2025-07-21
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2025-07-21
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2025-07-21
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-01-13
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-04-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-01-11
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-01-13
MBV	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2011-03-11
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2011-03-11
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2009-10-08
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2008-03-14
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2018-11-05
GXR	Cover, Burr Hole	Neurology	Class 2	882.5250	2014-01-13
HBW	Fastener, Plate, Cranioplasty	Neurology	Class 2	882.5360	2014-01-13
GWO	Plate, Cranioplasty, Preformed, Alterable	Neurology	Class 2	882.5320	2014-01-13
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-07-03
NRA	Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing	Unknown	Class 3	N/A	2006-05-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-01-13
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	Class 2	882.5330	2009-10-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-06-18
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2018-12-13
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-10-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2012-10-21
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2012-10-21
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2012-10-21
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2012-10-21
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2011-06-27
MAY	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	Orthopedic	Class 2	888.3353	2011-06-27
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2011-06-27
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2011-06-27
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2011-06-27
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2011-06-27
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2011-06-27
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2011-06-27
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Orthopedic	Class 3	888.3330	2011-06-27
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2011-06-27
JDL	Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)	Orthopedic	Class 3	888.3320	2011-06-27
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2012-11-14
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2012-11-14
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2019-10-31
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2019-10-31
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2019-10-31
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-12-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-12-11
MBV	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2017-08-22
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2017-08-22
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2017-08-22
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2017-08-22
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2017-08-22
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2011-04-06
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2011-04-06
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2011-04-06
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2011-04-06
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2011-04-06
JDL	Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)	Orthopedic	Class 3	888.3320	2011-04-06
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2011-04-06
MAY	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	Orthopedic	Class 2	888.3353	2011-04-06
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2011-04-06
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Orthopedic	Class 3	888.3330	2011-04-06
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2011-04-06
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-06-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-06-17
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2008-03-14
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2020-04-28
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2020-04-28
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2008-06-03
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2016-03-10
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2008-03-14
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2008-03-14
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2008-03-14
MBV	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2012-11-14
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-08-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-01-13
JEY	Plate, Bone	Dental	Class 2	872.4760	2014-01-13
HWT	Template	Orthopedic	Class 1	888.4800	1977-12-28
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2008-11-12
OQH	Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3350	2015-02-10
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2015-02-10
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2015-02-10
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2015-02-10
PBI	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive	Orthopedic	Class 2	888.3310	2015-02-10
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Orthopedic	Class 2	888.3353	2015-02-10
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2015-02-10
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2015-02-10
JEY	Plate, Bone	Dental	Class 2	872.4760	2014-01-13
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2008-02-05
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2008-02-05
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2008-02-05
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2008-02-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-06-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-06-18
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2018-12-11
JEY	Plate, Bone	Dental	Class 2	872.4760	2018-12-11
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2022-10-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-07-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-06-18
LXT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	Orthopedic	Class 2	888.3030	2012-06-18
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2016-04-29
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2008-02-15
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2009-10-08
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2009-10-08
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2009-10-08
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2009-10-08
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2009-10-08
LXT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	Orthopedic	Class 2	888.3030	2012-06-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-06-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-08-05
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2008-02-05
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-11-05
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2018-11-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-06-18
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2008-02-05
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2008-02-12
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2008-02-12
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2018-11-05
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2018-11-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-06-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-06-18
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2008-02-06
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2008-02-06
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2008-02-06
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2008-02-06
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2008-02-06
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-06-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-09-30
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2024-09-30
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Orthopedic	Class 3	888.3330	2011-07-01
MAY	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	Orthopedic	Class 2	888.3353	2026-06-04
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2026-06-04
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2026-06-04
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2026-06-04
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2026-06-04
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2026-06-04
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2009-05-26
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2009-05-26
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2012-06-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-07-10
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-07-10
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2021-01-08
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2021-01-08
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2021-01-08
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2021-01-08
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2021-01-08
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2021-01-08
MAY	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	Orthopedic	Class 2	888.3353	2021-01-08
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2021-01-08
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-03-27
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2012-11-08
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2012-11-08
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2012-11-08
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2012-11-08
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2012-11-08
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2012-11-08
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2012-11-08
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2012-11-08
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2008-03-14
JDG	Prosthesis, Hip, Femoral Component, Cemented, Metal	Orthopedic	Class 2	888.3360	2008-03-14
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2014-01-13
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-06-18
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-06-18
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2012-01-18
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2012-01-18
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2012-01-18
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2012-01-18
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2012-01-18
JDL	Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)	Orthopedic	Class 3	888.3320	2012-01-18
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2012-01-18
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Orthopedic	Class 3	888.3330	2012-01-18
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2012-01-18
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2012-01-18
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2018-01-10
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2018-01-10
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2018-01-10
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3660	2018-01-10
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2018-01-10
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2022-10-27
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2020-11-03
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2020-11-03
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2020-11-03
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2020-11-03
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-12-11
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-12-11
LXT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	Orthopedic	Class 2	888.3030	2014-03-28
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2021-02-25
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2016-03-10
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-06-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-06-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-06-18
LXT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	Orthopedic	Class 2	888.3030	2012-06-18

Official Correspondent

No official correspondent registered.

US Agent Details

Stephanie Lynch Business: Zimmer Biomet Email: Stephanie.Lynch@zimmerbiomet.com Phone: (715) 9289253

Related Public Records

Same Entity

Biomet, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1216032	Citra Labs LLC	Braintree, MA, US
3006946279	BIOMET FRANCE	Valence Drome, FR
1825034	BIOMET, INC.	WARSAW, IN, US
3006801265	Zhejiang Biomet Medical Products Co., Ltd.	Jinhua Zhejiang, CN
3002806535	BIOMET UK LTD.	BRIDGEND, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K983036	Biomet, Inc.	SINGLE AXLE TOTAL ELBOW	1999-04-30
K950761	Biomet, Inc.	INDEX ACETABULAT COMPONENT	1995-05-02
K031454	Biomet, Inc.	ACUMEN SURGICAL NAVIGATION SYSTEM	2004-07-08
K921181	Biomet, Inc.	MALLORY-HEAD TOTAL HIP SYSTEM	1994-02-16
K830313	Biomet, Inc.	CFE TOTAL HIP FEMORAL COMPONENT	1983-05-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-05	Biomet, Inc.	2	Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.
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-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-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.

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3017209758	NEBULA SURGICAL PRIVATE LIMITED	Rajkot Gujarat, IN
3015410662	Jabil Inc. (Wilson Drive)	W Chester, PA, US
8043862	AAP IMPLANTATE AG	BERLIN, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007923096. Last updated year: 2026. Please use registration number 3007923096 when referencing this establishment in official correspondence.