The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Ti-15 Mo Locking Distal Radius Plating System.
| Device ID | K031725 |
| 510k Number | K031725 |
| Device Name: | SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| 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 | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-03 |
| Decision Date | 2003-06-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6792424620 | K031725 | 000 |
| H6792424610 | K031725 | 000 |
| H6792424590 | K031725 | 000 |
| H6792424580 | K031725 | 000 |