The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Rapid Resorbable Fixation System.
Device ID | K062789 |
510k Number | K062789 |
Device Name: | SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM |
Classification | Plate, Bone |
Applicant | SYNTHES (USA) 1230 WILSON DRIVE West Chester, PA 19380 |
Contact | Jeffrey Dow |
Correspondent | Jeffrey Dow SYNTHES (USA) 1230 WILSON DRIVE West Chester, PA 19380 |
Product Code | JEY |
CFR Regulation Number | 872.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-09-18 |
Decision Date | 2007-02-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H98085163501S0 | K062789 | 000 |