K993335 is an FDA 510(k) clearance for the SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM. This device is classified as a Reamer (Class I - General Controls, product code HTO).
Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on June 12, 2000, 252 days after receiving the submission on October 4, 1999.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K993335 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 1999 |
| Decision Date | June 12, 2000 |
| Days to Decision | 252 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 |