The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Locking Calcaneal Plates.
Device ID | K991407 |
510k Number | K991407 |
Device Name: | SYNTHES LOCKING CALCANEAL PLATES |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
Contact | Sheri L Musgnung |
Correspondent | Sheri L Musgnung SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
Product Code | LXT |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-04-22 |
Decision Date | 1999-06-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H6792416270 | K991407 | 000 |
H6792416260 | K991407 | 000 |
H6792416250 | K991407 | 000 |
H6792416240 | K991407 | 000 |
H6792416230 | K991407 | 000 |
H6792416220 | K991407 | 000 |
H6792416190 | K991407 | 000 |
H6792416180 | K991407 | 000 |