Johnson & Johnson Medical (Depuy – Suzhou) Ltd.

Registered establishment in Suzhou, Jiangsu, China. 34 device types.

Registry build 21.09.26

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

FDA registration record for Johnson & Johnson Medical (Depuy – Suzhou) Ltd.
Registered name JOHNSON & JOHNSON MEDICAL (DEPUY – SUZHOU) LTD.
Status Registered
Registration expires 2026
Registration number 3006356043
FEI number 3006356043
Establishment type Manufacturer

Location

Address of Johnson & Johnson Medical (Depuy – Suzhou) Ltd.
City Suzhou
Province Jiangsu
Address NO.299, CHANGYANG STREET
Postal code 215126
Country China

What It Makes

Device types Johnson & Johnson Medical (Depuy – Suzhou) Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Appliance, Fixation, Spinal Interlaminal Class 2 Expedium, monarch, viper, Merlin 2016 11
Appliance, Fixation, Spinal Intervertebral Body Class 2 monarch, viper, expedium, Merlin 2016 14
Cement Obturator Class 2 Enduron, Hylamer, Change in pkg of UHMWPE components for Multicup, Ogee, cement restrictor, AMK poly tib & patella & tib insert, Synatomic 2007 3
Impactor Class 1 Impactor Instruments (Joint Recon), Viper, Concorde, Bengal, Expedium 1993 18
Instrument, Manual, Surgical, General Use Class 1 chisel, instrument guide, hammer, mallet, osteotome, rasp, retractor, saw, calipers 2001 110
Orthopedic Manual Surgical Instrument Class 1 broach, wire cutter, prosthesis driver, extractor, file, femoral neck punch, reamer, screwdriver, tamp wrench, etc., Attune Revision Assembly Femoral Shim Size 8, Attune, Pinnacle, Attune Revision Assembly Femoral Shim Size 6, Viper Prime and 7 more 2007 53
Orthosis, Spinal Pedicle Fixation Class 2 Expedium, monarch, viper, Merlin 2016 13
Orthosis, Spondylolisthesis Spinal Fixation Class 2 Expedium, monarch, viper, Merlin 2016 13
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Class 2 monarch, viper, expedium 2016 7
Prosthesis, Elbow, Hemi-, Radial, Polymer Class 2 Enduron, Hylamer, Change in pkg of UHMWPE components for Multicup, Ogee, cement restrictor, AMK poly tib & patella & tib insert, Synatomic 2007 3
Prosthesis, Elbow, Semi-Constrained, Cemented Class 2 Enduron, Hylamer, Change in pkg of UHMWPE components for Multicup, Ogee, cement restrictor, AMK poly tib & patella & tib insert, Synatomic 2007 3
Prosthesis, Hip, Hemi-, Femoral, Metal Class 2 Summit Hip System, Actis (hip), EMPHASYS Femoral Stems 2015 10
Prosthesis, Hip, Hemi-, Femoral, Metal Ball Class 2 Summit Hip System, Cathcart (hip), Articul/eze 2012 5
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Class 2 Summit Hip System, Actis (hip), Self-Centering Hip, EMPHASYS Femoral Stems, J-FX BiPOLAR HEAD, Enduron, Hylamer and 1 more 2007 14
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented Class 3 2012 2
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Class 2 Duraloc (hip), Summit Hip System, C-Stem AMT (hip), Articul/eze, EMPHASYS Femoral Stems, C-Stem (hip), Articul/eze 1996 15
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Class 2 Summit Hip System, Articul/eze (hip), C-Stem (hip), Elite (hip), C-Stem AMT (hip), Articul/eze, Duraloc (hip), Marathon and 9 more 2007 13
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Class 2 Duraloc (hip), Solution, Sector, Profile, Bantam, Duraloc (hip), Apex (hip), Summit Hip System, Articul/eze (hip), Summit (hip) and 5 more 1996 14
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Class 2 Summit Hip System, Summit (hip) 2007 9
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Class 2 Summit Hip System, Actis (hip), EMPHASYS Femoral Stems 2015 14
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Class 2 Enduron, Hylamer, Change in pkg of UHMWPE components for Multicup, Ogee, cement restrictor, AMK poly tib & patella & tib insert, Synatomic 2007 10
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Class 2 ATTUNE Medial Stabilized Fixed Bearing Insert, ATTUNE® Revision Knee System, Attune REV FB Insert Impactor 2016 12
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Class 2 Attune, ATTUNE Medial Stabilized Fixed Bearing Insert, Attune (Knee) 2011 8
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Class 2 Attune, ATTUNE Medial Stabilized Fixed Bearing Insert, Attune (Knee), ATTUNE® Revision Knee System, Attune REV FB Insert Impactor, PFC Knee and 8 more 2007 21
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing Class 3 ATTUNE Revision CRS Rotating Platform Insert Size 4 6 mm, Attune Revision RP Insert Trial Size 3 26MM, Attune Revision RP Insert Trial Size 5 10MM, Attune Revision RP Insert Trial Size 8 24MM, ATTUNE Revision CRS Rotating Platform Insert Size 4 14 mm, ATTUNE Revision CRS Rotating Platform Insert Size 5 20 mm and 54 more 2003 4
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Class 2 Global Advantage Shoulder, DePuy GLOBAL UNITE Platform Shoulder System, Delta (shoulder), Global Unite Platform Shoulder System Short Stem, Global FX Shoulder 2008 8
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Class 2 Global FX Shoulder 2009 6
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Class 2 Global Advantage Shoulder, DePuy GLOBAL UNITE Platform Shoulder System, Delta (shoulder), Global Unite Platform Shoulder System Short Stem, DELTA XTEND Reverse Shoulder System 2008 9
Screw, Fixation, Bone Class 2 2024 31
Shoulder Prosthesis, Reverse Configuration Class 2 DePuy GLOBAL UNITE Platform Shoulder System, Delta (shoulder), Global Unite Platform Shoulder System Short Stem, DELTA XTEND Reverse Shoulder System 2009 9
Template Class 1 guides, templates 1992 21
Thoracolumbosacral Pedicle Screw System Class 2 monarch, viper, expedium, Merlin 2016 15
Tray, Surgical, Instrument Class 1 instrument tray, instrument case, Attune Revision Solid RP Inserts Size 5-6 Case, Viper Prime, Attune Revision Solid RP Inserts Size 7-8 Case, Attune Revision Tibial Broach Caddy, Attune Revision Solid RP Inserts Size 3-4 Case and 1 more 1992 105
Wire, Surgical Class 2 2024 2

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.

510(k) clearances naming Johnson & Johnson Medical (Depuy – Suzhou) Ltd. or its listings
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.

FDA premarket approvals naming Johnson & Johnson Medical (Depuy – Suzhou) Ltd. or its listings
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

Other registered manufacturers in the same city
Manufacturer Device types
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Suzhou Meccan Import and Export Corp. 71
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B.Braun Medical (Suzhou) Co,.Ltd 37
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Microtek Computer Technology (Wu Jiang) Co., Ltd. 1
Sandstone Medical (Suzhou) Inc. 1
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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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer