K971978 is an FDA 510(k) clearance for the GRAFT HARVESTING SAWBLADES. This device is classified as a Blade, Saw, General & Plastic Surgery, Surgical (Class I - General Controls, product code GFA).
Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on June 18, 1997, 20 days after receiving the submission on May 29, 1997.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K971978 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 1997 |
| Decision Date | June 18, 1997 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GFA — Blade, Saw, General & Plastic Surgery, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |