The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Reamer/irrigator/aspirator (ria) System.
| Device ID | K993335 |
| 510k Number | K993335 |
| Device Name: | SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM |
| Classification | Reamer |
| Applicant | SYNTHES (USA) 1600 RUSSELL RD. Paoli, PA 19301 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung SYNTHES (USA) 1600 RUSSELL RD. Paoli, PA 19301 |
| Product Code | HTO |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-04 |
| Decision Date | 2000-06-12 |
| Summary: | summary |