The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 3.5mm Quadrilateral Surface Plates.
Device ID | K093928 |
510k Number | K093928 |
Device Name: | SYNTHES 3.5MM QUADRILATERAL SURFACE 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 | 2009-12-22 |
Decision Date | 2010-03-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H67902100327S0 | K093928 | 000 |
H67902100326S0 | K093928 | 000 |
H67902100325S0 | K093928 | 000 |