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 |
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|---|---|---|---|
| 00198506091216 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-06-03 |
| 00846338005719 | Forceps | ELLIQUENCE, LLC | 2026-06-02 |
| 00846338005726 | Forceps | ELLIQUENCE, LLC | 2026-06-02 |
| 00846338005757 | Forceps | ELLIQUENCE, LLC | 2026-06-02 |
| 00846338005764 | Forceps | ELLIQUENCE, LLC | 2026-06-02 |
| 00846338005771 | Forceps | ELLIQUENCE, LLC | 2026-06-02 |
| 00846338005788 | Forceps | ELLIQUENCE, LLC | 2026-06-02 |
| 00810189451490 | Surgical Design | Surgical Design, Inc. | 2026-05-29 |
| 09348811172174 | INKA | The Trustee for KAISER FAMILY TRUST | 2025-11-21 |
| G586NS5235002SPFB10 | Novo Surgical | NOVO SURGICAL, INC. | 2025-02-06 |
| G586NS20266610 | Novo Surgical | NOVO SURGICAL, INC. | 2024-02-22 |
| G586NS20286510 | Novo Surgical | NOVO SURGICAL, INC. | 2024-02-22 |
| G586NS20286810 | Novo Surgical | NOVO SURGICAL, INC. | 2024-02-22 |
| G586NS34214310 | Novo Surgical | NOVO SURGICAL, INC. | 2024-02-22 |
| G45333CC96MM900 | PEAK MED | Peak Medical Distribution Inc. | 2023-03-07 |
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