FDA Device Registration & Listing · Gotemba Shizuoka, JP · Registration 3016032497
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 |
|---|---|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2024-02-16 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2024-02-16 |
| HTO | Reamer | Orthopedic | Class 1 | 888.4540 | 2024-02-20 |
| GES | Blade, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2024-02-20 |
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2024-02-16 |
| HWT | Template | Orthopedic | Class 1 | 888.4800 | 2024-05-21 |
| HWX | Tap, Bone | Orthopedic | Class 1 | 888.4540 | 2024-02-20 |
| HTW | Bit, Drill | Orthopedic | Class 1 | 888.4540 | 2024-02-20 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2024-02-20 |
| HTR | Rasp | General, Plastic Surgery | Class 1 | 878.4800 | 2026-06-18 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 2024-02-20 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2024-02-13 |
| HWJ | Awl | Orthopedic | Class 1 | 888.4540 | 2024-09-11 |
| HTF | Curette | General, Plastic Surgery | Class 1 | 878.4800 | 2026-02-17 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 2024-02-20 |
| HXG | Tamp | Orthopedic | Class 1 | 888.4540 | 2026-02-17 |
| HTX | Rongeur | Orthopedic | Class 1 | 888.4540 | 2026-03-06 |
| HWN | Instrument, Compression | Orthopedic | Class 1 | 888.4540 | 2024-02-20 |
| GDF | Guide, Needle, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2024-02-16 |
| HXP | Instrument, Bending Or Contouring | Orthopedic | Class 1 | 888.4540 | 2026-02-17 |
| HXC | Wrench | Orthopedic | Class 1 | 888.4540 | 2024-02-16 |
| HXW | Bender | Orthopedic | Class 1 | 888.4540 | 2024-02-20 |
| HTJ | Gauge, Depth | Orthopedic | Class 1 | 888.4300 | 2024-02-20 |
| HXX | Screwdriver | Orthopedic | Class 1 | 888.4540 | 2024-02-20 |
| FZT | Cutter, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2024-02-16 |
No official correspondent registered.
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K922626 | Andronic Devices, Ltd. | ADEPT INSTRUMENT POSITIONING ACCESSORY | 1992-10-19 |
| K820290 | The Anspach Effort, Inc. | SELF RETAINING RETRACTOR FOR HAND SURG | 1982-03-05 |
| K760422 | Cutter Laboratories, Inc. | SURGICAL RETRACTOR | 1976-08-23 |
| K852723 | The Huxley Instrument Corp. | FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420 | 1985-07-15 |
| K873512 | Arthropedics, Inc. | SERRATED GRASPING FORCEPS, RIGHT | 1987-11-02 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0009-2007 | Smith & Nephew Inc | 1 | Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817. |
| Z-0010-2007 | Smith & Nephew Inc | 1 | Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486 |
| Z-0011-06 | Stryker Howmedica Osteonics Corp. | 1 | Allocraft TLIF Bone Inserter. |
| Z-0011-2007 | Smith & Nephew Inc | 1 | Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105 |
| Z-0013-2011 | Depuy Orthopaedics, Inc. | 1 | Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143
Catalog Number: 2570-00-000
The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3018033084 | NEXT GENERATION TOOLING INC | Akron, OH, US |
| 3038207124 | NATIVE ORTHOPAEDICS | Providence, RI, US |
| 3027516563 | STAR SPORTS MEDICINE CO., LTD. | Beijing, CN |
| 3021574846 | 3D LOGICS LLC | Hillsboro, OR, US |
| 3030089866 | ORTOLOG MEDIKAL SANAYI VE TICARET A.S. | Yenimahalle Ankara, TR |
3016032497 when referencing this establishment in official correspondence.