The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Tomofix Osteotomy System.
| Device ID | K023941 |
| 510k Number | K023941 |
| Device Name: | SYNTHES TOMOFIX OSTEOTOMY SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 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 | 2002-11-26 |
| Decision Date | 2003-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6794408740 | K023941 | 000 |
| H6794408640 | K023941 | 000 |
| H6794408530 | K023941 | 000 |
| H6794408430 | K023941 | 000 |
| H6794408340 | K023941 | 000 |
| H6794133090 | K023941 | 000 |