K863447 is an FDA 510(k) clearance for the STRYKER ORTHOPOWER 90 & ORTHOPOWER 90 SYSTEM II. This device is classified as a Motor, Surgical Instrument, Pneumatic Powered (Class I - General Controls, product code GET).
Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on September 29, 1986, 21 days after receiving the submission on September 8, 1986.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K863447 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 1986 |
| Decision Date | September 29, 1986 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GET — Motor, Surgical Instrument, Pneumatic Powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |