The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Large External Fixation Clamps-mr Safe.
| Device ID | K031428 |
| 510k Number | K031428 |
| Device Name: | SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| 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 | LXT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-06 |
| Decision Date | 2003-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6793900080 | K031428 | 000 |
| H6793900040 | K031428 | 000 |
| H6793900030 | K031428 | 000 |
| H6793900070 | K031428 | 000 |
| H6793900020 | K031428 | 000 |