K770118 is an FDA 510(k) clearance for the CARPENTER BONE CLAMP. This device is classified as a Clamp (Class I - General Controls, product code HXD).
Submitted by Stryker Corp. (Mchenry, US). The FDA issued a Cleared decision on January 26, 1977, 5 days after receiving the submission on January 21, 1977.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K770118 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 1977 |
| Decision Date | January 26, 1977 |
| Days to Decision | 5 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | HXD — Clamp |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |