The following data is part of a premarket notification filed by Synthes Inc with the FDA for Synthes Patient Specific Plate.
| Device ID | K122647 |
| 510k Number | K122647 |
| Device Name: | SYNTHES PATIENT SPECIFIC PLATE |
| Classification | Plate, Bone |
| Applicant | SYNTHES INC 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Alan T Haley |
| Correspondent | Alan T Haley SYNTHES INC 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-30 |
| Decision Date | 2013-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H980SD4801120 | K122647 | 000 |
| H980SD4801110 | K122647 | 000 |
| H980SD4801100 | K122647 | 000 |
| H980SD4801020 | K122647 | 000 |
| H980SD4801010 | K122647 | 000 |
| H980SD4801000 | K122647 | 000 |