The following data is part of a premarket notification filed by Synthes with the FDA for Synthes Sternal Fixation System.
Device ID | K093772 |
510k Number | K093772 |
Device Name: | SYNTHES STERNAL FIXATION SYSTEM |
Classification | Plate, Fixation, Bone |
Applicant | SYNTHES 1301 Goshen Parkway West Chester, PA 19380 |
Contact | Andrea M Tasker |
Correspondent | Andrea M Tasker SYNTHES 1301 Goshen Parkway 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 | 2009-12-08 |
Decision Date | 2010-03-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H980460172S0 | K093772 | 000 |
H980460171S0 | K093772 | 000 |