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 |
|---|---|---|---|
| B382SD914341100 | Surgical Direct | Surgical Direct, Inc. | 2026-07-13 |
| B382SD922707180 | Surgical Direct | Surgical Direct, Inc. | 2026-07-10 |
| B382SD9227771090 | Surgical Direct | Surgical Direct, Inc. | 2026-07-10 |
| B382SD92274510120 | Surgical Direct | Surgical Direct, Inc. | 2026-07-10 |
| B382SD922738990 | Surgical Direct | Surgical Direct, Inc. | 2026-07-10 |
| B382SD9227381020 | Surgical Direct | Surgical Direct, Inc. | 2026-07-10 |
| B382SD9227381010 | Surgical Direct | Surgical Direct, Inc. | 2026-07-10 |
| B382SD9227381000 | Surgical Direct | Surgical Direct, Inc. | 2026-07-10 |
| B382SD922738100 | Surgical Direct | Surgical Direct, Inc. | 2026-07-10 |
| B382SD922734080 | Surgical Direct | Surgical Direct, Inc. | 2026-07-10 |
| B382SD922734070 | Surgical Direct | Surgical Direct, Inc. | 2026-07-10 |
| B382SD922734060 | Surgical Direct | Surgical Direct, Inc. | 2026-07-10 |
| B382SD922707190 | Surgical Direct | Surgical Direct, Inc. | 2026-07-10 |
| B382SD922707170 | Surgical Direct | Surgical Direct, Inc. | 2026-07-10 |
| B382SD922707160 | Surgical Direct | Surgical Direct, Inc. | 2026-07-10 |
| B382SD922707150 | Surgical Direct | Surgical Direct, Inc. | 2026-07-10 |
| B382SD922707140 | Surgical Direct | Surgical Direct, Inc. | 2026-07-10 |
| B382SD92270212C0 | Surgical Direct | Surgical Direct, Inc. | 2026-07-10 |
| B382SD9227021010 | Surgical Direct | Surgical Direct, Inc. | 2026-07-10 |
| 00810168190396 | NA | PACIFIC INSTRUMENTS, INC. | 2026-06-26 |
| 00198506091216 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-06-03 |
| 00846338005726 | Forceps | ELLIQUENCE, LLC | 2026-06-02 |
| 00846338005719 | Forceps | ELLIQUENCE, LLC | 2026-06-02 |
| 08809695610400 | AnyPlus® Cervical PEEK Cage System | GS Medical Co., Ltd. | 2025-03-17 |
| 08809695610394 | AnyPlus® Cervical PEEK Cage System | GS Medical Co., Ltd. | 2025-03-17 |
| 08809695610387 | AnyPlus® Cervical PEEK Cage System | GS Medical Co., Ltd. | 2025-03-17 |
| 08809695610370 | AnyPlus® Cervical PEEK Cage System | GS Medical Co., Ltd. | 2025-03-17 |
| B382SD9238331020 | Surgical Direct | Surgical Direct, Inc. | 2024-06-25 |
| B382SD921220120 | Surgical Direct | Surgical Direct, Inc. | 2022-12-01 |
| 00192896078819 | FERRIS-SMITH KERRISON | SONTEC INSTRUMENTS, INC. | 2018-09-20 |