Product code HWA
- Device name
- Impactor
- 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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|---|---|---|---|
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| 04719886914849 | U-Motion II | UNITED ORTHOPEDIC CORP. | 2026-10-15 |
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| 00889795151742 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
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| 00190776434694 | Millennium | Avalign Technologies, Inc. | 2026-10-12 |
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| 09421028119184 | Enztec Partial Knee Femoral Impactor - Angled Arm | ENZTEC LIMITED | 2026-10-07 |
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| 08057968718913 | CUP IMPACTOR M8 | HPF SRL | 2022-09-08 |
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| 08057968716810 | ACCESSORY CONN. M8x1 | HPF SRL | 2022-09-02 |
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| 00840096401172 | Viant Medical, LLC | VIANT MEDICAL | 2020-05-14 |
| 00840096401196 | Viant Medical, LLC | VIANT MEDICAL | 2020-05-14 |