K760977 is an FDA 510(k) clearance for the CHARNLEY FEMUR DRILL #1 AND #2. This device is classified as a Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (Class I - General Controls, product code HWE).
Submitted by Codman & Shurtleff, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 16, 1976, 13 days after receiving the submission on November 3, 1976.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K760977 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 1976 |
| Decision Date | November 16, 1976 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | - |
| Product Code | HWE - Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |