Changzhou Biomet Medical Devices Co., Ltd.
Registered establishment in Changzhou, Jiangsu, China. 54 device types.
Changzhou Biomet Medical Devices Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Template, Plate, Bone and 52 other device types. Its earliest product listing with the FDA dates from 1977.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3007923096 |
| FEI number | 3007923096 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Changzhou |
|---|---|
| Province | Jiangsu |
| Address | No. 235 Chuangxin Road |
| Postal code | 213031 |
| Country | China |
Group
Changzhou Biomet Medical Devices Co., Ltd. is one of 2 plants registered under Biomet, Inc..
| Plant | City | Device types |
|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | 74 |
What It Makes
Clearances
No clearance names Changzhou Biomet Medical Devices Co., Ltd. as applicant. 81 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K251270 | 2026-05-19 | LPH | Traditional | Biomet, Inc. |
| K202232 | 2021-02-19 | PHX | Traditional | Biomet Manufacturing Corp |
| K200196 | 2020-12-08 | LZO | Traditional | Biomet Orthopedics |
| K193038 | 2020-10-28 | MBF | Traditional | Biomet Manufacturing Corp |
| K193373 | 2020-04-15 | PHX | Traditional | Biomet, Inc. |
| K173767 | 2018-04-06 | HRS | Traditional | Biomet, Inc. |
| K172502 | 2018-01-03 | PHX | Traditional | Biomet Manufacturing Corp |
| K171054 | 2017-07-28 | JWH | Traditional | Biomet, Inc. |
| K150867 | 2015-06-10 | HSB | Traditional | Biomet, Inc. |
| K143697 | 2015-03-30 | HRS | Traditional | Biomet Manufacturing Corp |
| K142882 | 2015-02-10 | LPH | Traditional | Biomet, Inc. |
| K142746 | 2014-12-29 | LPH | Traditional | Biomet Manufactuting Corp. |
| K142933 | 2014-12-23 | JWH | Traditional | Biomet, Inc. |
| K140622 | 2014-05-13 | HRS | Traditional | Biomet, Inc. |
| K133939 | 2014-04-01 | HRS | Traditional | Biomet, Inc. |
| K132873 | 2013-12-11 | MBH | Traditional | Biomet, Inc. |
| K132898 | 2013-11-19 | HRS | Traditional | Biomet Manufacturing Corp |
| K131867 | 2013-10-29 | HRS | Traditional | Biomet, Inc. |
| K132704 | 2013-10-09 | LXT | Traditional | Biomet, Inc. |
| K131670 | 2013-07-03 | HRS | Traditional | Biomet, Inc. |
| K121874 | 2012-11-23 | PBI | Traditional | Biomet Manufacturing Corp |
| K120030 | 2012-08-17 | LPH | Traditional | Biomet Manufacturing Corp |
| K113550 | 2012-02-29 | JWH | Traditional | Biomet Manufacturing Corp |
| K120121 | 2012-02-16 | PHX | Special | Biomet, Inc. |
| K110400 | 2011-09-30 | KWA | Traditional | Biomet Manufacturing Corp |
| K102580 | 2011-03-03 | JWH | Traditional | Biomet Manufacturing Corp |
| K103755 | 2011-01-21 | KWA | Special | Biomet Manufacturing Corp |
| K103408 | 2010-12-16 | HRS | Special | Depuy Orthopaedics, Inc. |
| K093293 | 2010-10-22 | JWH | Traditional | Biomet, Inc. |
| K101086 | 2010-09-03 | KWA | Traditional | Biomet, Inc. |
| K101421 | 2010-06-15 | HRS | Special | Depuy Orthopaedics, Inc. |
| K091294 | 2009-07-24 | HRS | Traditional | Depuy Orthopaedics, Inc. |
| K090877 | 2009-06-26 | HRS | Traditional | Depuy Orthopaedics, Inc. |
| K083843 | 2009-03-20 | HRS | Traditional | Depuy Orthopaedics, Inc. |
| K082300 | 2009-02-18 | HRS | Traditional | Depuy Orthopaedics, Inc. |
| K082446 | 2008-10-15 | KWA | Traditional | Biomet, Inc. |
| K080642 | 2008-07-09 | PHX | Traditional | Biomet, Inc. |
| K072832 | 2007-12-14 | HRS | Traditional | Depuy Orthopaedics, Inc. |
| K072083 | 2007-10-25 | HRS | Traditional | Depuy Orthopaedics, Inc. |
| K063614 | 2007-02-20 | KWA | Traditional | Biomet Manufacturing Corp |
| K063732 | 2007-01-18 | JWH | Traditional | Biomet Manufacturing Corp |
| K063002 | 2006-10-31 | KWA | Special | Biomet Manufacturing Corp |
| K060716 | 2006-06-12 | MBF | Traditional | Biomet Manufacturing Corp |
| K051569 | 2005-09-29 | JDI | Traditional | Biomet, Inc. |
| K040610 | 2004-06-04 | KWS | Traditional | Biomet Manufacturing Corp |
| K033489 | 2004-06-02 | MBH | Traditional | Biomet, Inc. |
| K032396 | 2003-08-21 | JDI | Special | Biomet, Inc. |
| K023546 | 2003-01-17 | JWH | Traditional | Biomet, Inc. |
| K023357 | 2002-11-06 | LPH | Special | Biomet Orthopedics |
| K010212 | 2001-02-14 | MBV | Special | Biomet, Inc. |
| K990830 | 2000-04-11 | LPH | Traditional | Biomet, Inc. |
| K991807 | 1999-07-08 | LPH | Traditional | Biomet, Inc. |
| K990032 | 1999-02-18 | JDI | Traditional | Biomet, Inc. |
| K984408 | 1999-02-12 | LPH | Traditional | Biomet, Inc. |
| K984154 | 1999-02-11 | JDI | Traditional | Biomet, Inc. |
| K984028 | 1999-01-19 | KWL | Traditional | Biomet, Inc. |
| K983710 | 1998-12-02 | JDI | Traditional | Biomet, Inc. |
| K974558 | 1998-03-04 | JDI | Traditional | Biomet, Inc. |
| K972629 | 1997-10-09 | KTT | Traditional | Depuy Intl., Ltd. |
| K971890 | 1997-08-07 | JDI | Traditional | Biomet, Inc. |
| K960303 | 1996-06-21 | LPH | Traditional | Biomet, Inc. |
| K955350 | 1996-02-16 | LZO | Traditional | Biomet, Inc. |
| K953925 | 1996-01-31 | LZO | Traditional | Biomet, Inc. |
| K954485 | 1995-10-31 | HWC | Traditional | ACE Medical |
| K950618 | 1995-05-10 | HRS | Traditional | ACE Medical |
| K945115 | 1995-05-02 | JDI | Traditional | Biomet, Inc. |
| K942479 | 1994-09-20 | JDG | Traditional | Biomet, Inc. |
| K921301 | 1994-02-16 | LPH | Traditional | Biomet, Inc. |
| K926047 | 1993-03-31 | HWC | Traditional | Ace Orthopedic Manufacturing Co. |
| K915132 | 1992-02-11 | JWH | Traditional | Biomet, Inc. |
| K912245 | 1991-08-19 | JWH | Traditional | Biomet, Inc. |
| K911684 | 1991-06-27 | JDI | Traditional | Biomet, Inc. |
| K905048 | 1991-01-30 | HWC | Traditional | ACE Medical |
| K903810 | 1990-10-16 | HWC | Traditional | ACE Medical |
| K903811 | 1990-10-16 | HWC | Traditional | ACE Medical |
| K882831 | 1988-08-01 | HWC | Traditional | Buckman Co., Inc. |
| K874670 | 1987-12-17 | HWC | Traditional | Buckman Co., Inc. |
| K871539 | 1987-08-17 | HSB | Traditional | Buckman Co., Inc. |
| K872859 | 1987-08-17 | HWC | Traditional | ACE Medical |
| K853259 | 1985-11-01 | KMC | Traditional | Biomet, Inc. |
| K833175 | 1983-12-22 | KWY | Traditional | Biomet, Inc. |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Closed |
|---|---|---|---|---|
| 2022-06-02 | Class II | Process control | One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates | 2024-02-12 |
PMA Approvals
A premarket approval is the Class III route: granted on clinical evidence, not on equivalence to a device already on the market.
| PMA number | Decision | Trade name | Product code | Held by |
|---|---|---|---|---|
| P010014 | 2018-04-19 | Oxford Patrial Knee System | NRA | Biomet Manufacturing Corp |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.