The following data is part of a premarket notification filed by Citieffe with the FDA for Citieffe-titanium Cannulated Screw.
Device ID | K113388 |
510k Number | K113388 |
Device Name: | CITIEFFE-TITANIUM CANNULATED SCREW |
Classification | Screw, Fixation, Bone |
Applicant | CITIEFFE 110 E. GRANADA BLVD. SUITE 209 Ormond Beach, FL 32176 |
Contact | Claude Berthoin |
Correspondent | Claude Berthoin CITIEFFE 110 E. GRANADA BLVD. SUITE 209 Ormond Beach, FL 32176 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-11-16 |
Decision Date | 2012-06-05 |