K953961 is an FDA 510(k) clearance for the OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM. This device is classified as a Table, Operating-room, Pneumatic (Class I - General Controls, product code FWW).
Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on November 29, 1995, 99 days after receiving the submission on August 22, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4960.
| 510(k) Number | K953961 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 1995 |
| Decision Date | November 29, 1995 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FWW — Table, Operating-room, Pneumatic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4960 |