Product code HWX
- Device name
- Tap, Bone
- 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#
Related GUDID Devices#
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|---|---|---|---|
| 00842078115602 | Jones Union | EXTREMITY MEDICAL, LLC | 2026-10-29 |
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| 00810112597417 | TriLEAP | Synthes GmbH | 2026-02-10 |
| 00810112597424 | TriLEAP | Synthes GmbH | 2026-02-10 |
| 00810112597431 | TriLEAP | Synthes GmbH | 2026-02-10 |
| 10888857590687 | YUKON OCT Spinal System | VB Spine LLC | 2025-12-09 |
| 10888857590670 | YUKON OCT Spinal System | VB Spine LLC | 2025-12-09 |
| 10888857590663 | YUKON OCT Spinal System | VB Spine LLC | 2025-12-09 |
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| 00643169060760 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2022-10-07 |
| 00643169377691 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2022-10-07 |
| 00643169377707 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2022-10-07 |
| 00888118084323 | RESORB X | KLS-Martin L.P. | 2018-09-27 |
| 00643169085855 | N/A | MEDTRONIC SOFAMOR DANEK, INC. | 2017-12-09 |
| 00643169651890 | N/A | MEDTRONIC SOFAMOR DANEK, INC. | 2017-12-09 |
| 00643169651906 | N/A | MEDTRONIC SOFAMOR DANEK, INC. | 2017-12-09 |
| 00613994872685 | N/A | MEDTRONIC SOFAMOR DANEK, INC. | 2017-12-09 |
| 00613994872746 | N/A | MEDTRONIC SOFAMOR DANEK, INC. | 2017-12-08 |
| 10886705020355 | HEALIX KNOTLESS | DEPUY MITEK, LLC | 2017-03-17 |
| 10886705013852 | NA | DEPUY MITEK, LLC | 2015-09-01 |
| 10886705013845 | NA | DEPUY MITEK, LLC | 2015-09-01 |
| 10886705013838 | NA | DEPUY MITEK, LLC | 2015-09-01 |
| 10886705013821 | NA | DEPUY MITEK, LLC | 2015-09-01 |