K954915 is an FDA 510(k) clearance for the FLEXIBLE INTRAMEDULLARY REAMER. This device is classified as a Reamer (Class I - General Controls, product code HTO).
Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 28, 1995, 63 days after receiving the submission on October 26, 1995.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K954915 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 1995 |
| Decision Date | December 28, 1995 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HTO — Reamer |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4540 |