The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Large Combination Clamp And Dynamization Clip - Mr Safe.
| Device ID | K030390 |
| 510k Number | K030390 |
| Device Name: | SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Bonnie Smith |
| Correspondent | Bonnie Smith SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | LXT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-05 |
| Decision Date | 2003-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6793900060 | K030390 | 000 |
| H6793900050 | K030390 | 000 |