FDA Device Registration & Listing · SAINT-SOUPPLETS Seine-et-Marne, FR · Registration 3005360851
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | Class 2 | 880.6850 | 2021-09-16 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2023-01-23 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2023-01-23 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2022-02-03 |
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | Orthopedic | Class 2 | 888.3353 | 2022-02-03 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2022-02-03 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Orthopedic | Class 2 | 888.3358 | 2022-02-03 |
| PBI | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive | Orthopedic | Class 2 | 888.3310 | 2022-02-03 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2022-02-03 |
| OQH | Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | Orthopedic | Class 2 | 888.3350 | 2022-02-03 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Orthopedic | Class 2 | 888.3310 | 2022-02-03 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2017-12-23 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2017-12-23 |
| HWT | Template | Orthopedic | Class 1 | 888.4800 | 2017-12-23 |
| LRP | Tray, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2017-12-23 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2021-10-08 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Orthopedic | Class 2 | 888.3560 | 2021-10-08 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3565 | 2021-10-08 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K243425 | Talladium España, SL | Guided DAS Surgical Kit | 2025-07-22 |
| K213209 | K1 Medical, LLC | EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device | 2021-12-28 |
| K012105 | Symmetry Medical, Inc. | POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM | 2002-08-02 |
| K243317 | Infinitum Eta, Ltd. | NUVENTUS NV.C Surgical Cassette and Tray | 2025-02-11 |
| K112536 | Covidien | SONICISION STERILIZATION TRAY | 2012-04-19 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0036-2013 | Medtronic Sofamor Danek USA Inc | 2 | ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132.
Orthopedic.
This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for
single use, this instrument may be re-used. |
| Z-0037-2013 | Medtronic Sofamor Danek USA Inc | 2 | ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132.
Orthopedic.
This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for
single use, this instrument may be re-used. |
| Z-0038-2013 | Medtronic Sofamor Danek USA Inc | 2 | PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132.
Orthopedic.
This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for
single use, this instrument may be re-used. |
| Z-0040-05 | Zimmer Spine, Inc. | 2 | ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays. |
| Z-0001-2013 | Synthes USA HQ, Inc. | 2 | MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine.
The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3021119558 | Assembly-Tek LLC | Dayton, OH, US |
| 3014191428 | TydenBrooks | Tallapoosa, GA, US |
| 3008132392 | Medicom Asia-Pacific Holdings Limited. Taiwan Branch | Wujie Township Yilan, TW |
| 1526531 | STERIS Corporation | CLEVELAND, OH, US |
| 3005706667 | TURNER MEDICAL INC. | Athens, AL, US |
3005360851 when referencing this establishment in official correspondence.