Product code HXJ
- Device name
- Staple Driver
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.4540
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K964953 | IN-TAC BONE ANCHOR SYSTEM | Influence, Inc. | 1997-02-13 |
| K962372 | UROTAC BONE ANCHOR INSERTER | Influence, Inc. | 1996-08-19 |
| K930205 | ELECTRIC WIRE DRIVER, MODEL 2640E | Micro Surgical Instruments Corp. | 1993-08-02 |
| K834515 | FIXATION STAPLE KIT - DLIDE HAMMER | Stryker Corp. | 1984-04-23 |
| K830255 | OSTEOTOMY BONE STAPLE | Techmedica, Inc. | 1983-03-09 |
| K830456 | STAPLE INSERTER-EXTRACTOR FOR ARTHROS | Instrument Makar, Inc. | 1983-03-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 03760225718902 | In2Bones | IN2BONES | 2024-12-13 |
| 05055662969788 | COGNiTiON™ Staple System | ORTHO SOLUTIONS HOLDINGS LIMITED | 2024-04-01 |
| 05055662969771 | COGNiTiON™ Staple System | ORTHO SOLUTIONS HOLDINGS LIMITED | 2024-04-01 |
| 05055662969764 | COGNiTiON™ Staple System | ORTHO SOLUTIONS HOLDINGS LIMITED | 2024-04-01 |
| 05055662969757 | COGNiTiON™ Staple System | ORTHO SOLUTIONS HOLDINGS LIMITED | 2024-04-01 |
| 05055662969740 | COGNiTiON™ Staple System | ORTHO SOLUTIONS HOLDINGS LIMITED | 2024-04-01 |
| 05055662969733 | COGNiTiON™ Staple System | ORTHO SOLUTIONS HOLDINGS LIMITED | 2024-04-01 |
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| M224INS92309 | Inion OTPS Pin Instruments | Inion Oy | 2020-05-08 |
| M224INS92889 | Inion FreedomPin Instruments | Inion Oy | 2020-05-08 |
| M224INS92859 | Inion FreedomPin Instruments | Inion Oy | 2020-05-08 |
| M224INS92819 | Inion FreedomPin Instruments | Inion Oy | 2020-05-08 |
| 06438408007293 | Inion FreedomPin Instruments | Inion Oy | 2020-05-08 |
| 06438408004704 | Inion OTPS Pin Instruments | Inion Oy | 2020-05-08 |
| 06438408004551 | Inion FreedomPin Instruments | Inion Oy | 2020-05-08 |
| 06438408004520 | Inion FreedomPin Instruments | Inion Oy | 2020-05-08 |
| 06438408004452 | Inion FreedomPin Instruments | Inion Oy | 2020-05-08 |
| 10381780051930 | LARGE UNI-CLIP® | NEWDEAL | 2017-05-31 |
| 10381780051947 | LARGE UNI-CLIP® | NEWDEAL | 2017-05-31 |
| 00888867002586 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867002579 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867002555 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867002548 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867002500 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867002494 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867002470 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867002463 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867002456 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867002449 | Arthrex® | ARTHREX, INC. | 2017-02-15 |