The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Hamstring Loop.
Device ID | K003700 |
510k Number | K003700 |
Device Name: | SYNTHES HAMSTRING LOOP |
Classification | Screw, Fixation, Bone |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Contact | Thomas M Maguire |
Correspondent | Thomas M Maguire SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-12-01 |
Decision Date | 2001-02-20 |