The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Tomofix Osteotomy System.
Device ID | K023941 |
510k Number | K023941 |
Device Name: | SYNTHES TOMOFIX OSTEOTOMY SYSTEM |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
Contact | Lisa M Boyle |
Correspondent | Lisa M Boyle SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
Product Code | KTT |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-11-26 |
Decision Date | 2003-01-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H6794408740 | K023941 | 000 |
H6794408640 | K023941 | 000 |
H6794408530 | K023941 | 000 |
H6794408430 | K023941 | 000 |
H6794408340 | K023941 | 000 |
H6794133090 | K023941 | 000 |