Product code HTX
- Device name
- Rongeur
- 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 |
|---|---|---|---|
| K874954 | MANUAL RONGEUR | Solway, Inc. | 1987-12-30 |
| K841620 | FRONT RADIUS CUTTER | Plastafil, Inc. | 1984-09-20 |
| K841621 | BACK RADIUS CUTTER | Plastafil, Inc. | 1984-09-20 |
| K780397 | ORTHOPEDIC FORCEPS | Orthopedic Equipment Co., Inc. | 1978-03-22 |
| K760325 | SURGICAL INSTRUMENTS, ORTHOPEDIC | Depuy, Inc. | 1976-08-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B382SD922812030 | Surgical Direct | Surgical Direct, Inc. | 2026-08-07 |
| 00190776422912 | Millennium | Avalign Technologies, Inc. | 2026-08-03 |
| 00190776422929 | Millennium | Avalign Technologies, Inc. | 2026-08-03 |
| B382SD4319D0 | Surgical Direct | Surgical Direct, Inc. | 2026-08-03 |
| B382SD480007LH0 | Surgical Direct | Surgical Direct, Inc. | 2026-08-03 |
| B382SD480046220 | Surgical Direct | Surgical Direct, Inc. | 2026-08-03 |
| B382SD482030LH0 | Surgical Direct | Surgical Direct, Inc. | 2026-08-03 |
| B382SD482047PH0 | Surgical Direct | Surgical Direct, Inc. | 2026-08-03 |
| B382SD482058LH0 | Surgical Direct | Surgical Direct, Inc. | 2026-08-03 |
| B382SD482505LH0 | Surgical Direct | Surgical Direct, Inc. | 2026-08-03 |
| B382SD482506LH0 | Surgical Direct | Surgical Direct, Inc. | 2026-08-03 |
| B382SD4829130 | Surgical Direct | Surgical Direct, Inc. | 2026-08-03 |
| B382SD4882030 | Surgical Direct | Surgical Direct, Inc. | 2026-08-03 |
| B382SD488603SLH0 | Surgical Direct | Surgical Direct, Inc. | 2026-08-03 |
| B382SD1450500050 | Surgical Direct | Surgical Direct, Inc. | 2026-07-31 |
| 00190776422455 | Millennium | Avalign Technologies, Inc. | 2026-07-31 |
| B382SD914848050 | Surgical Direct | Surgical Direct, Inc. | 2026-07-28 |
| B382SD914848060 | Surgical Direct | Surgical Direct, Inc. | 2026-07-28 |
| B382SD9148641090 | Surgical Direct | Surgical Direct, Inc. | 2026-07-28 |
| B382SD91486410900 | Surgical Direct | Surgical Direct, Inc. | 2026-07-28 |
| B382SD9148941000 | Surgical Direct | Surgical Direct, Inc. | 2026-07-28 |
| B382SD9148001020 | Surgical Direct | Surgical Direct, Inc. | 2026-07-27 |
| 00190776405861 | Millennium | Avalign Technologies, Inc. | 2026-07-26 |
| 00190776405885 | Millennium | Avalign Technologies, Inc. | 2026-07-26 |
| 00840183532154 | BR Surgical, LLC | BR Surgical, LLC | 2026-07-22 |
| 00840183532161 | BR Surgical, LLC | BR Surgical, LLC | 2026-07-22 |
| 00840183532178 | BR Surgical, LLC | BR Surgical, LLC | 2026-07-22 |
| 04058749058734 | NA | Fehling Instruments GmbH & Co. KG | 2026-07-17 |
| B382SD914830190 | Surgical Direct | Surgical Direct, Inc. | 2024-10-24 |
| B382SD9212271030 | Surgical Direct | Surgical Direct, Inc. | 2023-02-21 |