Product code HWJ
- Device name
- Awl
- 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 |
|---|---|---|---|
| K895587 | CROSS MEDICAL PRODUCT PEDICLE AWL | Cross Medical Products, Inc. | 1990-01-04 |
| K875223 | DANNINGER ORTHOPAEDIC AWL | Danninger Medical Technology, Inc. | 1988-02-17 |
| K880045 | ACROMED AWL/PUNCH, DEPTH GAUGE | Buckman Co., Inc. | 1988-02-17 |
| K870779 | ACROMED WALLIE-HEINIG TROCHAR | Buckman Co., Inc. | 1987-03-09 |
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| 18257200051175 | PROVIEW | Orthofix US LLC | 2026-07-17 |
| 18257200163571 | PILLAR SA Ti | Orthofix US LLC | 2026-07-17 |
| 18257200163588 | PILLAR SA Ti | Orthofix US LLC | 2026-07-17 |
| 18257200163595 | PILLAR SA Ti | Orthofix US LLC | 2026-07-17 |
| B8034803400 | ORTHOMED | ORTHO-MED, INC. | 2026-07-16 |
| B8034803410 | ORTHOMED | ORTHO-MED, INC. | 2026-07-16 |
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