The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Cannulated Titanium Humeral Nail System.
Device ID | K033071 |
510k Number | K033071 |
Device Name: | SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM |
Classification | Nail, Fixation, Bone |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Contact | Lisa M Boyle |
Correspondent | Lisa M Boyle SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Product Code | JDS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-29 |
Decision Date | 2003-11-05 |
Summary: | summary |