The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Tomofix(tm) Meial High Tibia Plate, Small.
| Device ID | K100676 |
| 510k Number | K100676 |
| Device Name: | SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Contact | Karl J Nittinger |
| Correspondent | Karl J Nittinger SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-10 |
| Decision Date | 2010-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6794408310 | K100676 | 000 |