The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Modification To Synthes (usa) Reamer Irrigator Aspirator (ria) System.
| Device ID | K013527 |
| 510k Number | K013527 |
| Device Name: | MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM |
| Classification | Reamer |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Bonnie J Smith |
| Correspondent | Bonnie J Smith SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | HTO |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-23 |
| Decision Date | 2001-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679351718S0 | K013527 | 000 |
| H679352251S0 | K013527 | 000 |
| H679352252S0 | K013527 | 000 |
| H679352253S0 | K013527 | 000 |
| H679352254S0 | K013527 | 000 |
| H679352255S0 | K013527 | 000 |
| H679352256S0 | K013527 | 000 |
| H679352257S0 | K013527 | 000 |
| H679352258S0 | K013527 | 000 |
| H679352259S0 | K013527 | 000 |
| 07611819739192 | K013527 | 000 |
| 07611819739208 | K013527 | 000 |
| H679314745S0 | K013527 | 000 |
| H679314746S0 | K013527 | 000 |
| H679352250S0 | K013527 | 000 |