The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Tomofix Medial Distal Femur Plates.
| Device ID | K081353 |
| 510k Number | K081353 |
| Device Name: | SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-14 |
| Decision Date | 2008-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679021082000 | K081353 | 000 |
| H679440895S0 | K081353 | 000 |
| H6794408950 | K081353 | 000 |
| H679440885S0 | K081353 | 000 |
| H6794408850 | K081353 | 000 |