K954483 is an FDA 510(k) clearance for the STRYKER SAGITTAL SAW ATTACHMENT. This device is classified as a Blade, Saw, General & Plastic Surgery, Surgical (Class I - General Controls, product code GFA).
Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on January 30, 1996, 125 days after receiving the submission on September 27, 1995.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K954483 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 1995 |
| Decision Date | January 30, 1996 |
| Days to Decision | 125 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 |