Rongeur
FDA product code HTX · Class I (low risk) · 21 CFR 888.4540 · Orthopedic
5510(k) clearances
0PMA approvals
7recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K874954 | Manual RongeurHTX · Traditional | Solway, Inc. | 12/30/1987SE |
| K841621 | Back Radius CutterHTX · Traditional | Plastafil, Inc. | 09/20/1984SE |
| K841620 | Front Radius CutterHTX · Traditional | Plastafil, Inc. | 09/20/1984SE |
| K780397 | Orthopedic ForcepsHTX · Traditional | Orthopedic Equipment Co., Inc. | 03/22/1978SE |
| K760325 | Surgical Instruments, OrthopedicHTX · Traditional | Depuy, Inc. | 08/03/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0952-2025 Class II | ECONO STERILE medical procedure kits labeled as: ECONO STERILE LEMPERT BONE RONG 6.25"…Reports of various packaging issues that may result in a breach of the sterile barrier. | Sklar Instruments | 12/03/2024Open, Classified |
| Z-2668-2017 Class II | EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Reamer // Catalog #: 321-45-38…Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the… | Exactech, Inc. | 05/25/2017Terminated |
| Z-2667-2017 Class II | EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Catalog #: 321-45-01Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the… | Exactech, Inc. | 05/25/2017Terminated |
| Z-2666-2017 Class II | EXACTECH Equinoxe Modular Reverse Pilot-Tip Reamer, Catalog #: 321-25-38, Catalog #:…Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the… | Exactech, Inc. | 05/25/2017Terminated |
| Z-2665-2017 Class II | EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer - Catalog #: 321-25-01Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the… | Exactech, Inc. | 05/25/2017Terminated |
| Z-2664-2017 Class II | EXACTECH Equinoxe Glenoid Reamer - Catalog #: 321-05-38, Catalog #: 321-05-42, and…Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the… | Exactech, Inc. | 05/25/2017Terminated |
| Z-2663-2017 Class II | EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the… | Exactech, Inc. | 05/25/2017Terminated |