The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Resorbable Tack System.
Device ID | K000560 |
510k Number | K000560 |
Device Name: | SYNTHES (USA) RESORBABLE TACK SYSTEM |
Classification | Plate, Bone |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
Contact | Bonnie J Smith |
Correspondent | Bonnie J Smith SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
Product Code | JEY |
CFR Regulation Number | 872.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-02-18 |
Decision Date | 2001-01-09 |