The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Ria System - Expanded Indications.
| Device ID | K042899 |
| 510k Number | K042899 |
| Device Name: | SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS |
| Classification | Reamer |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung SYNTHES (USA) 1690 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 | 2004-10-20 |
| Decision Date | 2005-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679352260S0 | K042899 | 000 |
| H679352265S0 | K042899 | 000 |
| H679352264S0 | K042899 | 000 |
| H679352263S0 | K042899 | 000 |
| H679352262S0 | K042899 | 000 |
| H679352261S0 | K042899 | 000 |
| H679352229S0 | K042899 | 000 |