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 |