The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Rapid Resorbable Tack System.
Device ID | K050204 |
510k Number | K050204 |
Device Name: | SYNTHES RAPID RESORBABLE TACK SYSTEM |
Classification | Plate, Bone |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Contact | Sheri L Musgnung |
Correspondent | Sheri L Musgnung SYNTHES (USA) 1690 RUSSELL RD. 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 | 2005-01-28 |
Decision Date | 2005-03-04 |
Summary: | summary |