The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Large Fragment Locking Compression Plate (lcp) System-t Plate.
Device ID | K010766 |
510k Number | K010766 |
Device Name: | SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Contact | Bonnie Smith |
Correspondent | Bonnie Smith SYNTHES (USA) 1690 RUSSELL RD. 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 | 2001-03-14 |
Decision Date | 2001-06-12 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H6792401810 | K010766 | 000 |
H6792401610 | K010766 | 000 |
H6792401410 | K010766 | 000 |
H6794401810 | K010766 | 000 |
H6794401610 | K010766 | 000 |
H6794401410 | K010766 | 000 |