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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00643169524699 | Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | 2026-09-20 |
| 04054896015002 | Awl | Silony Medical GmbH | 2026-09-18 |
| 04054896079356 | Awl | Silony Medical GmbH | 2026-09-18 |
| 04054896079349 | Awl | Silony Medical GmbH | 2026-09-18 |
| 04054896079332 | Awl | Silony Medical GmbH | 2026-09-18 |
| 04054896079325 | Awl | Silony Medical GmbH | 2026-09-18 |
| 04054896069289 | Awl | Silony Medical GmbH | 2026-09-18 |
| 04054896056777 | Awl | Silony Medical GmbH | 2026-09-18 |
| 04054896052601 | Awl | Silony Medical GmbH | 2026-09-18 |
| 04054896052595 | Awl | Silony Medical GmbH | 2026-09-18 |
| 04054896032818 | Awl | Silony Medical GmbH | 2026-09-18 |
| 04054896024318 | Awl | Silony Medical GmbH | 2026-09-18 |
| 04054896024301 | Awl | Silony Medical GmbH | 2026-09-18 |
| 04054896024295 | Awl | Silony Medical GmbH | 2026-09-18 |
| 04054896024288 | Awl | Silony Medical GmbH | 2026-09-18 |
| 04054896021669 | Awl | Silony Medical GmbH | 2026-09-18 |
| 04054896014999 | Awl | Silony Medical GmbH | 2026-09-18 |
| 04054896005577 | Awl | Silony Medical GmbH | 2026-09-18 |
| 04054896005560 | Awl | Silony Medical GmbH | 2026-09-18 |
| 04054896005553 | Awl | Silony Medical GmbH | 2026-09-18 |
| 04054896002927 | Awl | Silony Medical GmbH | 2026-09-18 |
| 04054896000787 | Awl | Silony Medical GmbH | 2026-09-18 |
| 04054896000770 | Awl | Silony Medical GmbH | 2026-09-18 |
| B7685657210 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2024-10-03 |
| B7685657110 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2024-10-02 |
| B7682460260 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-06-09 |
| B7684892400 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-04-10 |
| B7682460050 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2023-01-10 |
| B7682460060 | Buxton BioMedical | BUXTON BIOMEDICAL, INC. | 2022-12-09 |
| 10888857461352 | SAHARA™ Stabilization System | VB Spine LLC | 2020-09-23 |