FDA Registration
Active
🇨🇳 China
Zhejiang Biomet Medical Products Co., Ltd.
Reg #: 3006801265
·
FEI: 3006801265
·
Expires 2026
Products
74
Proprietary Names
166
Establishment Types
2
Classifications
74
Registration Details
- Registration Name
- Zhejiang Biomet Medical Products Co., Ltd.
- Registration Number
- 3006801265
- FEI Number
- 3006801265
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 980 Shenli Road
- City
- Jinhua Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K150503
- PMA Number
- P010014
Owner / Operator
- Firm Name
- Biomet, Inc.
- Operator Number
- 1825034
- Address
- 56 East Bell Dr., PO Box 587
- City
- Warsaw
- State
- IN
- Postal Code
- 46582
- Country
- US
US Agent
- Business Name
- Zimmer Biomet
- Contact Name
- Stephanie Lynch
- Address
- 1800 W Center St
- City
- Warsaw
- State
- IN
- ZIP
- 46580
- Country
- US
- [email protected]
- Phone
- 715 9289253
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 1992-12-08 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2015-03-26 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2015-03-26 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2015-03-26 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2015-03-26 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2015-03-26 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2015-03-26 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2015-03-26 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2015-03-26 |
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | OQH | Class 2 | Orthopedic | No | 2015-03-26 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive | PBI | Class 2 | Orthopedic | No | 2015-03-26 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2015-03-26 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2008-02-04 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2016-08-09 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 1977-12-28 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2016-11-09 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2012-06-18 |
| Bone Mill | LYS | Class 1 | Orthopedic | No | 1992-11-03 |
| Template | HWT | Class 1 | Orthopedic | No | 1977-12-28 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2013-04-03 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2013-04-03 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer | MBV | Class 2 | Orthopedic | No | 2013-04-03 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2012-06-18 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | MAY | Class 2 | Orthopedic | No | 2011-06-27 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2011-06-27 |
| Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | KWA | Class 3 | Orthopedic | No | 2011-06-27 |
| Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | JDL | Class 3 | Orthopedic | No | 2011-06-27 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2022-09-16 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2022-09-16 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2022-09-16 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2022-09-16 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2022-09-16 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 1994-01-07 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2003-12-17 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 1993-03-18 |
| Reamer | HTO | Class 1 | Orthopedic | No | 1978-03-24 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 1977-12-28 |
| Knee Arthroplasty Implantation System | OOG | Class 2 | Orthopedic | No | 2011-02-11 |
| Wrench | HXC | Class 1 | Orthopedic | No | 1978-03-22 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2012-06-18 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 1978-03-22 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2011-08-17 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2001-06-16 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2014-04-23 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 1994-06-01 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 1998-08-27 |
| Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing | NRA | Class 3 | Unknown | No | 2006-05-19 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2024-09-30 |
| Nail, Fixation, Bone, Metallic | NDH | Class 2 | Orthopedic | No | 2011-05-05 |
| Plate, Fixation, Bone, Non-Spinal, Metallic | NDF | Class 2 | Orthopedic | No | 2011-05-05 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2008-03-17 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 1977-12-28 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2003-12-17 |
| Punch, Femoral Neck | HWP | Class 1 | Orthopedic | No | 1977-12-28 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 1978-03-22 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2019-05-14 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2019-05-14 |
| Awl | HWJ | Class 1 | Orthopedic | No | 1977-12-28 |
| Impactor | HWA | Class 1 | Orthopedic | No | 1977-12-28 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2012-06-18 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2012-06-18 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2012-06-18 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 1977-12-28 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 1977-12-28 |
| Driver, Surgical, Pin | GFC | Class 1 | General, Plastic Surgery | No | 1977-12-28 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 1998-08-27 |
| Bender | HXW | Class 1 | Orthopedic | No | 1977-12-28 |
| Extractor | HWB | Class 1 | Orthopedic | No | 1977-12-28 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 1977-12-28 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2003-01-08 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 1977-12-28 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2023-08-22 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 1977-12-28 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 1977-12-28 |
Proprietary Names
SURGICAL INSTRUMENT
BIOMET TRAY,
ECHO BI-METRIC MICROPLASTY
GROWTH CONTROL PLATING SYSTEM
UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS
NEXGEN POROUS
CALIPERS
BIOMET
Persona Partial Knee System
G7 ACETABULAR SYSTEM
LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSIO
PLATE, MODEL 824077010, COMPRESSION FUSION PLATE,
BONE MILL
SMALL FRAGMENT LOCKING PLATING SYSTEM
BIOMET TEMPLATE
VANGUARD XP
KNEE SYSTEM
131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S
STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S
ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM
DEPUY FRACTURE AND FUSION PLATING SYSTEM
PEANUT GROWTH CONTROL PLATING SYSTEM
824677021, 22, 824071001, 824071101, 824671001, 82467
CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021
ACE 100 DEGREES TUBULAR PLATE
ECHO BI-METRIC MICROPLASTY HIP SYSTEM
LAPIDUS PLATE,
3.5MM INLINE FUSION PLATE
3.5MM MTP PLATE (LEFT AND RIGHT)
DISTAL VOLAR RADIUS PLATING SYSTEMS
Continuum and Trilogy IT Acetabular Systems; Longevity IT Highly Crosslinked Pol Elevated Liners
Persona Natural Tibia Baseplates
TAPERLOC COMPLETE, SIZE 5 AND 6
DVR LATERAL PLATE
DVR ULNA PLATE
DVR DORSAL PLATE
Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)
PROSTHESIS,HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED
Identity Shoulder System
A. L. P. S. Clavicle Plating System
DEPUY ACE TROCHANTERIC SIDE PLATE
VANGUARD 360 OSSEOTI
TIBIAL SLEEVE AUGMENT
BIOMET SURGICAL
HAMMER
FREEDOM CONSTRAINED LINERS
VANGUARD 360 REVISION KNEE SYSTEM
ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM
NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE CO
PROFILE AND MULTIDIRECTIONAL SCREWS
PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW
BIOMET OSTEOTOME
NEXT GENERATION KNEE SYSTEM
BIOMET MANUAL
Precision Cannula
Z1 Cemented Hip System
Zimmer Biomet Ceramic Heads
Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head
LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM
BIOMET REAMER
POSTERIOR LATERAL PLATES
GAUGE
Gauge Biomet Depth
BIOMET DEPTH
Zimmer Persona Personalized Knee System
Avenir Complete Hip System
Identity Revision Humeral Stems
E1 AVANTAGE HEAD
SIGNATURE PLANNER; SIGNATURE GUIDES
BIOMET WRENCH
Persona Personalized Knee System
OLECRANON PLATES MODEL 131218704-708; 851318704-708, 1312182
MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES,
SCREWDRIVER
VUELOC ANTERIOR CERVICAL PLATE
Comprehensive Shoulder System
Zimmer Biomet X Series
Persona Natural Tibia Baseplate
EBI VUELOCK CERVICAL PLATE SYSTEM
(BEARINGS / TRAYS)
OXFORD FIXED LATERAL
BEARING PARTIAL KNEE REPLACEMENT
BIOMET MODULAR FEMORAL REVISION SYSTEM
Persona Revision Knee System
A.L.P.S. CALCANEAL PLATING SYSTEM
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Zimmer Persona Knee System
CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY
4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5
1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS
ACCESSORIES AND ATTACHMENTS
SURGICAL, ORTHOPEDIC,
BIOMET INSTRUMENT
AC-POWERED MOTOR
GUIDE
BIOMET SURGICIAL
OXFORD MENISCAL UNICOM
Affixus Tibial and Antegrade Femoral Nailing System
JACE Medical Thoracic Plating System
COMPREHENSIVE PRIMARY SHOULDER STEMS
E1 SERIES A PATELLAE, STANDARD 3-PEG, E1 SERIES A PATELLAE, THIN 3-PEG, E1 SERIES PATELLAE, ASYMMETRICAL, 3-PEG
BIOMET CANNULATED
SCREW SYSTEM
ANATOMIC LOCKING PLATING SYSTEM
EBI DYNAFIX VS OSTEOTOMY SYSTEM
BLADE
BIOMET SAW
COMPREHENSIVE REVERSE SHOULDER
PROSTHESIS DRIVER
BIOMET BROACH
G7 FREEDOM AND OFFSET LINERS, FREEDOM HEAD, SIZE 32
TAPERLOC COMPLETE
SIZE 4MM & XR 123
TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM
OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD
NECK PUNCH
BIOMET FEMORAL
VERSA-DIAL HUMERAL HEAD PROSTHESIS
SIGNATURE GUIDES
SIGNATURE PLANNER,
Zimmer Persona the Personalized Knee System
2.5MM INLINE FUSION PLATE
BIOMET RASP
Vanguard Knee System
BIOMET HEADLESS COMPRESSION AND TWIST OFF SCREWS
Zimmer Knee Joint Replacement Prostheses MR Labeling
BIOMET AWL
TAPERLOC COMPLETE MICROPLASTY STEM
BIOMET IMPACTOR
TRAUMA INTERNAL FIXATION SYSTEMS
Comprehensive® Reverse Shoulder
BIOMET DRILL BIT
Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners
MANUAL CHISEL
VANGUARD COMPLETE KNEE SYSTEM
DEPUY AE TK2 HIP SCREW SYSTEM
Z1 Hip System
DISTAL RADIUS VOLAR RIM PLATE STANDARD AND NARROW
PIN, DRIVER
BIOMET SURGICAL,
Biomet Proximal Humerus Plating System
ORTHOPEDIC CUTTING
INSTRUMENT
BIOMET BENDER
EXTRACTORS
RETRACTOR
ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS
BIOMET GENERAL
ORTHOPEDIC
MANUAL INSTRUMENT
TAP
BIOMET BONE
TITANIUM VERSA-DIAL
PROSTHESIS
HUMERAL HEAD
Vanguard XP Knee System
3MM BIOMET CANNULATED SCREW SYSTEM
Biomet Headless Compression and Twist-Off Screws
Sternal Closure System
DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM
ARCOMXL POLYETHYLENE LINERS
SURGICAL CLAMP
ACE RECONSTRUCTIVE PLATE
ARCOS INTERLOCKING DISTAL STEMS
SURGICAL PLIERS
Zimmer
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device