The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) 2.0mm Titanium T-plate.
| Device ID | K072758 |
| 510k Number | K072758 |
| Device Name: | SYNTHES (USA) 2.0MM TITANIUM T-PLATE |
| Classification | Plate, Cranioplasty, Preformed, Alterable |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Contact | Andrea M Tasker |
| Correspondent | Andrea M Tasker SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Product Code | GWO |
| CFR Regulation Number | 882.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-28 |
| Decision Date | 2007-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887587054698 | K072758 | 000 |