The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Modular Blade Plate System.
| Device ID | K080109 |
| 510k Number | K080109 |
| Device Name: | SYNTHES (USA) MODULAR BLADE PLATE SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Single Component |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Contact | Jill R Sherman |
| Correspondent | Jill R Sherman SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Product Code | KTW |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-15 |
| Decision Date | 2008-03-20 |
| Summary: | summary |