The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Rapidsorb Plus Screw System.
Device ID | K093464 |
510k Number | K093464 |
Device Name: | RAPIDSORB PLUS SCREW SYSTEM |
Classification | Screw, Fixation, Intraosseous |
Applicant | SYNTHES (USA) 1230 WILSON DRIVE West Chester, PA 19380 |
Contact | Susan Lewandowski |
Correspondent | Susan Lewandowski SYNTHES (USA) 1230 WILSON DRIVE West Chester, PA 19380 |
Product Code | DZL |
CFR Regulation Number | 872.4880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-11-06 |
Decision Date | 2010-01-25 |
Summary: | summary |