Johnson & Johnson Medical (Depuy – Suzhou) Ltd.
Registered establishment in Suzhou, Jiangsu, China. 34 device types.
Johnson & Johnson Medical (Depuy – Suzhou) Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Impactor, Template and 32 other device types. Its earliest product listing with the FDA dates from 1992.
Registration
| Registered name | JOHNSON & JOHNSON MEDICAL (DEPUY – SUZHOU) LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3006356043 |
| FEI number | 3006356043 |
| Establishment type | Manufacturer |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | NO.299, CHANGYANG STREET |
| Postal code | 215126 |
| Country | China |
What It Makes
Clearances
No clearance names Johnson & Johnson Medical (Depuy – Suzhou) Ltd. as applicant. 66 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 |
|---|---|---|---|---|
| K231873 | 2024-01-19 | MEH | Traditional | Depuy Ireland UC |
| K231526 | 2023-12-19 | KWY | Traditional | Depuy Ireland UC |
| K220216 | 2022-07-22 | JDI | Traditional | Depuy Ireland UC |
| K212710 | 2021-09-15 | PHX | Special | Depuy Ireland UC |
| K211609 | 2021-08-25 | JWH | Traditional | Depuy Ireland UC |
| K211657 | 2021-08-05 | LZO | Traditional | Depuy Ireland UC |
| K202098 | 2020-11-25 | PHX | Traditional | Depuy Ireland UC |
| K202472 | 2020-10-21 | LPH | Special | Depuy Orthopaedics, Inc. |
| K200245 | 2020-04-24 | NKB | Traditional | Medos International Sàrl |
| K183077 | 2019-05-17 | PHX | Traditional | Depuy (Ireland) |
| K170339 | 2018-04-26 | LZO | Traditional | Depuy Orthopaedics, Inc. |
| K170748 | 2018-01-11 | PHX | Traditional | Depuy Ireland UC |
| K170806 | 2017-06-15 | JWH | Traditional | Depuy (Ireland) |
| K160907 | 2016-07-19 | MEH | Traditional | Depuy (Ireland) |
| K160904 | 2016-07-01 | NKB | Traditional | Medos International Sarl |
| K160700 | 2016-06-10 | JWH | Traditional | Depuy (Ireland) |
| K150862 | 2015-09-25 | MEH | Traditional | Depuy Orthopaedics, Inc. |
| K142460 | 2014-10-01 | KWP | Special | Johnson and Johnson |
| K120599 | 2013-04-30 | LPH | Traditional | Depuy Orthopaedics, Inc. |
| K111136 | 2012-06-14 | NKB | Traditional | Depuy Spine, Inc. |
| K120174 | 2012-06-11 | PHX | Traditional | Depuy France |
| K111433 | 2011-08-30 | OIY | Traditional | Depuy Orthopaedics, Inc. |
| K101433 | 2010-12-10 | OIY | Traditional | Depuy Orthopaedics, Inc. |
| K082500 | 2008-11-18 | JWH | Traditional | Depuy Orthopaedics, Inc. |
| K082239 | 2008-08-29 | JDI | Special | Depuy Orthopaedics, Inc. |
| K081620 | 2008-06-30 | KWS | Special | Depuy Orthopaedics, Inc. |
| K042959 | 2004-12-22 | JDI | Special | Depuy Orthopaedics, Inc. |
| K040544 | 2004-05-28 | LPH | Traditional | Depuy Intl., Ltd. |
| K033901 | 2004-03-31 | NKB | Traditional | Depuy Spine, Inc. |
| K040166 | 2004-02-23 | JWH | Traditional | Depuy Orthopaedics, Inc. |
| K033272 | 2004-02-05 | JWH | Traditional | Depuy Orthopaedics, Inc. |
| K032151 | 2003-09-26 | JWH | Special | Depuy Intl., Ltd. |
| K030122 | 2003-02-05 | LWJ | Special | Depuy Orthopaedics, Inc. |
| K023453 | 2002-11-13 | JDI | Special | Depuy Orthopaedics, Inc. |
| K013352 | 2001-12-17 | JDI | Traditional | Depuy Orthopaedics, Inc. |
| K003421 | 2000-12-01 | JDI | Special | Depuy Orthopaedics, Inc. |
| K000575 | 2000-03-10 | KWS | Traditional | Depuy Orthopaedics, Inc. |
| K992065 | 1999-07-12 | KWS | Special | Depuy Orthopaedics, Inc. |
| K984541 | 1999-01-14 | KWT | Special | Depuy Orthopaedics, Inc. |
| K983014 | 1998-10-27 | LPH | Traditional | Johnson & Johnson Professionals, Inc. |
| K982918 | 1998-10-05 | JDI | Traditional | Depuy Orthopaedics, Inc. |
| K980801 | 1998-05-29 | KWY | Traditional | Johnson & Johnson Professionals, Inc. |
| K980513 | 1998-04-14 | JDI | Traditional | Depuy Orthopaedics, Inc. |
| K972596 | 1997-11-12 | LPH | Traditional | Depuy Intl., Ltd. |
| K971189 | 1997-07-17 | JWH | Traditional | Johnson & Johnson Professionals, Inc. |
| K963309 | 1996-11-12 | LPH | Traditional | Depuy Intl., Ltd. |
| K961186 | 1996-09-17 | LPH | Traditional | Depuy Intl., Ltd. |
| K961685 | 1996-07-10 | JWH | Traditional | Johnson & Johnson Professionals, Inc. |
| K952830 | 1996-01-18 | JWH | Traditional | Johnson & Johnson Professionals, Inc. |
| K940743 | 1995-09-18 | KWY | Traditional | Depuy Intl., Ltd. |
| K952740 | 1995-08-18 | LPH | Traditional | Depuy Intl., Ltd. |
| K950010 | 1995-05-15 | JWH | Traditional | Johnson & Johnson Professionals, Inc. |
| K951301 | 1995-04-18 | LPH | Traditional | Depuy Intl., Ltd. |
| K943462 | 1994-12-21 | JWH | Traditional | Johnson & Johnson Professionals, Inc. |
| K903084 | 1990-10-03 | LZY | Traditional | Depuy Intl., Ltd. |
| K900832 | 1990-05-04 | JDI | Traditional | Depuy Intl., Ltd. |
| K900891 | 1990-03-12 | JDI | Traditional | Depuy Intl., Ltd. |
| K884796 | 1989-03-29 | JWH | Traditional | Johnson & Johnson Professionals, Inc. |
| K882234 | 1988-10-20 | JWH | Traditional | Johnson & Johnson Professionals, Inc. |
| K883460 | 1988-10-11 | JDI | Traditional | Depuy Intl., Ltd. |
| K871867 | 1988-04-08 | JDI | Traditional | Thackray USA |
| K851422 | 1985-09-18 | JDI | Traditional | Joint Medical Products Corp. |
| K843909 | 1984-11-15 | JDI | Traditional | Depuy Intl., Ltd. |
| K830927 | 1983-07-19 | JWH | Traditional | Johnson & Johnson Professionals, Inc. |
| K812672 | 1981-10-08 | KWY | Traditional | Depuy Intl., Ltd. |
| K802627 | 1980-12-16 | JDI | Traditional | Cintor Orthopaedic Div. |
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 |
|---|---|---|---|---|
| P070026 | 2026-06-03 | CERAMAX CERAMIC HIP SYSTEM | MRA | Depuy Orthopaedics, Inc. |
| P830055 | 2024-02-27 | LCS® Total Knee System | NJL | Depuy Intl., Ltd. |
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.