The following data is part of a premarket notification filed by Synthes (usa) Products Llc with the FDA for Depuy Synthes Tomofix Osteotomy System.
| Device ID | K141796 |
| 510k Number | K141796 |
| Device Name: | DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) PRODUCTS LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Kara Elkin |
| Correspondent | Kara Elkin SYNTHES (USA) PRODUCTS LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-03 |
| Decision Date | 2014-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679031200690 | K141796 | 000 |
| H679031200680 | K141796 | 000 |
| H67904120551S0 | K141796 | 000 |
| H679041205510 | K141796 | 000 |
| H67904120550S0 | K141796 | 000 |
| H679041205500 | K141796 | 000 |