Panels › Orthopedic › Product code HTX · Class 1
Rongeur
Regulation 888.4540
0510(k)s in 12 months (5 all time)
0recalls in 12 months (7 all time)
0recalls that name a 510(k)
Top companies in HTX
| Company | 510(k)s | Recalls |
|---|---|---|
| Exactech, Inc. | 0 | 6 |
| Plastafil, Inc. | 2 | 0 |
| Depuy, Inc. | 1 | 0 |
| Orthopedic Equipment Co., Inc. | 1 | 0 |
| Sklar Instruments | 0 | 1 |
| Solway, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
ECONO STERILE LEMPERT BONE RONG 6.25" STER25, Model Number 96-4780A; orthopedic surgery Open, Classified |
HTX | None listed |
| May 25, 2017 | Exactech, Inc. EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Reamer // Catalog #: 321-45-38, Catalog #: 321-45-42 and Catalog #: 321-45-46 Terminated |
HTX | None listed |
| May 25, 2017 | Exactech, Inc. EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Catalog #: 321-45-01 Terminated |
HTX | None listed |
| May 25, 2017 | Exactech, Inc. EXACTECH Equinoxe Modular Reverse Pilot-Tip Reamer, Catalog #: 321-25-38, Catalog #: 321-25-42 and
Catalog #: 321-25-46 Terminated |
HTX | None listed |
| May 25, 2017 | Exactech, Inc. EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer - Catalog #: 321-25-01 Terminated |
HTX | None listed |
| May 25, 2017 | Exactech, Inc. EXACTECH Equinoxe Glenoid Reamer - Catalog #: 321-05-38, Catalog #: 321-05-42, and Catalog #: 321-05-46 Terminated |
HTX | None listed |
| May 25, 2017 | Exactech, Inc. EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01 Terminated |
HTX | None listed |
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