Data / Medical devices / China / Zhejiang Biomet Medical Products Co., Ltd.
Zhejiang Biomet Medical Products Co., Ltd.: FDA-registered device maker in Jinhua Zhejiang, China, 66 510(k) clearances and 1 PMA approval
Zhejiang Biomet Medical Products Co., Ltd. is registered with the FDA (registration 3006801265) in Jinhua Zhejiang, China. It lists 73 device types. The FDA files 66 510(k) clearances and 1 PMA approval under its listings, the newest dated October 28, 2020. Registered through 2027. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3006801265
- Address
- 980 Shenli Road, Jinhua Zhejiang, China, 321016
- Owner or operator
- Zimmer Inc (1825034)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 28, 1977
- Registered through
- 2027
- Brand names listed
- (BEARINGS / TRAYS), 1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS, 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S, 2.5MM INLINE FUSION PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT), 3MM BIOMET CANNULATED SCREW SYSTEM, 4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 28, 2020 | K193038 | Comprehensive Shoulder System | MBF | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| April 15, 2020 | K193373 | Comprehensive® Reverse Shoulder | PHX | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| February 7, 2019 | K190035 | Biomet Headless Compression and Twist-Off Screws | HWC | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| April 6, 2018 | K173767 | A. L. P. S. Clavicle Plating System | HRS | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| November 3, 2016 | K161592 | Persona Partial Knee System | HSX | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| October 6, 2015 | K151603 | Arcos One-piece Femoral Revision System | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| March 30, 2015 | K143697 | Biomet Proximal Humerus Plating System | HRS | Substantially Equivalent | Biomet Manufacturing | accessdata.fda.gov |
| March 25, 2015 | K150503 | Echo Bi-Metric Microplasty Line Extension | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| February 10, 2015 | K142882 | G7 Freedom and Offset Liners, Freedom Head, Size 32 | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| December 30, 2014 | K143188 | 3.Omm Biomet Cannulated Screw System | HWC | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| December 23, 2014 | K142933 | Biomet Tibial trays | JWH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| December 18, 2014 | K143009 | Echo Bi-Metric Microplasty Hip System | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| November 13, 2014 | K142658 | Biomet Headless Compression and Twist-off Screws | HWC | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| September 10, 2014 | K140390 | TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS | MBF | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| July 30, 2014 | K140883 | VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT | MBH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| July 3, 2014 | K140902 | E1 SERIES A PATELLAE, STANDARD 3-PEG, E1 SERIES A PATELLAE, THIN 3-PEG, E1 SERIES PATELLAE, ASYMMETRICAL, 3-PEG | JWH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| June 3, 2014 | K140891 | BIOMET CANNULATED SCREW SYSTEM | HWC | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| May 13, 2014 | K140622 | DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE | HRS | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| April 2, 2014 | K140257 | SIGNATURE PLANNER, SIGNATURE GUIDES | MBH | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| March 28, 2014 | K133940 | OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) | HRY | Substantially Equivalent | Biomet UK, Ltd. | accessdata.fda.gov |
| November 19, 2013 | K132898 | A.L.P.S. CALCANEAL PLATING SYSTEM | HRS | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| October 29, 2013 | K131867 | 2.5MM INLINE FUSION PLATE | HRS | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| October 9, 2013 | K132704 | DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW | LXT | Substantially Equivalent | Biomet | accessdata.fda.gov |
| July 3, 2013 | K131670 | LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT) | HRS | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| March 20, 2013 | K122160 | VANGUARD XP KNEE SYSTEM | MBH | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| November 23, 2012 | K121874 | G7 ACETABULAR SYSTEM | PBI | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| October 22, 2012 | K122277 | OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM | HRY | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| August 17, 2012 | K120030 | TAPERLOC COMPLETE SIZE 4MM AND XR 123 | LPH | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| May 16, 2012 | K121149 | VANGUARD SSK 360 REVISION KNEE SYSTEM | JWH | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| March 12, 2012 | K111663 | TRAUMA INTERNAL FIXATION SYSTEMS | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| February 29, 2012 | K113550 | VANGUARD COMPLETE KNEE SYSTEM | JWH | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| October 31, 2011 | K112345 | DISTAL VOLAR RADIUS PLATING SYSTEMS | LXT | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| September 30, 2011 | K110400 | TAPERLOC COMPLETE MICROPLASTY STEM | KWA | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| February 2, 2011 | K102795 | SIGNATURE PLANNER; SIGNATURE GUIDES | JWH | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| January 21, 2011 | K103755 | TAPERLOC COMPLETE, SIZE 5 AND 6 | KWA | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| January 14, 2011 | K101336 | E1 AVANTAGE HEAD | LPH | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| December 16, 2010 | K103408 | POSTERIOR LATERAL PLATES | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| December 7, 2010 | K100469 | ARCOS INTERLOCKING DISTAL STEMS | KWA | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| October 22, 2010 | K093293 | VANGUARD 360 REVISION KNEE SYSTEM | JWH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| July 23, 2010 | K101240 | CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467 | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| June 15, 2010 | K101421 | MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708; 851318704-708, 131218204 | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| April 16, 2010 | K093880 | PEANUT GROWTH CONTROL PLATING SYSTEM | HRS | Substantially Equivalent | Ebi, L.P. | accessdata.fda.gov |
| February 2, 2010 | K093474 | DEPUY FRACTURE AND FUSION PLATING SYSTEM | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| September 25, 2009 | K090757 | BIOMET MODULAR FEMORAL REVISION SYSTEM | KWA | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| June 26, 2009 | K090877 | PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWS | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| March 31, 2009 | K090492 | 1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| March 20, 2009 | K083843 | LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| March 11, 2009 | K090374 | STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S | LXT | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| February 18, 2009 | K082300 | ANATOMIC LOCKING PLATING SYSTEM | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| July 9, 2008 | K080642 | COMPREHENSIVE REVERSE SHOULDER | PHX | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| December 14, 2007 | K072832 | ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| November 7, 2007 | K072423 | 4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY. | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| October 25, 2007 | K072083 | SMALL FRAGMENT LOCKING PLATING SYSTEM | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| May 7, 2007 | K070823 | GROWTH CONTROL PLATING SYSTEM | HRS | Substantially Equivalent | Biomet Trauma | accessdata.fda.gov |
| December 8, 2006 | K062997 | ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS | LZO | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| June 12, 2006 | K060716 | VERSA-DIAL HUMERAL HEAD PROSTHESIS | MBF | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| May 30, 2006 | K060692 | COMPREHENSIVE PRIMARY SHOULDER STEMS | MBF | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| April 26, 2005 | K050932 | DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM | LXT | Substantially Equivalent | Hand Innovations, Inc. | accessdata.fda.gov |
| March 8, 2005 | K042051 | ARCOMXL POLYETHYLENE LINERS | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| January 23, 2003 | K030047 | FREEDOM CONSTRAINED LINERS | KWZ | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| August 12, 2002 | K021749 | EBI DYNAFIX VS OSTEOTOMY SYSTEM | NDF | Substantially Equivalent | Ebi, L.P. | accessdata.fda.gov |
| May 17, 2001 | K010551 | EBI DYNAFIX VS OSTEOTOMY SYSTEM | NDF | Substantially Equivalent | Ebi, L.P. | accessdata.fda.gov |
| October 9, 1997 | K972629 | DEPUY AE TK2 HIP SCREW SYSTEM | KTT | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| April 30, 1997 | K970503 | DEPUY ACE TROCHANTERIC SIDE PLATE | HRS | Substantially Equivalent | Depuy Ace Medical Co. | accessdata.fda.gov |
| July 27, 1992 | K920738 | ACE 100 DEGREES TUBULAR PLATE | HRS | Substantially Equivalent | Ace Orthopedic Manufacturing Co. | accessdata.fda.gov |
| March 14, 1991 | K905595 | ACE RECONSTRUCTIVE PLATE | HRS | Substantially Equivalent | Ace Medical Co. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 21, 2004 | P010014 | OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM | NRA | 107 | October 6, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
- All makers of Plate, Fixation, Bone
- All makers of Screw, Fixation, Bone
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Updated October 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.