The following data is part of a premarket notification filed by Synergy Surgical Technologies, Llc with the FDA for Synergy Cannulated Screw System.
Device ID | K092082 |
510k Number | K092082 |
Device Name: | SYNERGY CANNULATED SCREW SYSTEM |
Classification | Screw, Fixation, Bone |
Applicant | SYNERGY SURGICAL TECHNOLOGIES, LLC 11234 EL CAMINO REAL, SUITE 200 San Diego, CA 92130 |
Contact | Kevin Thomas |
Correspondent | Kevin Thomas SYNERGY SURGICAL TECHNOLOGIES, LLC 11234 EL CAMINO REAL, SUITE 200 San Diego, CA 92130 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-07-09 |
Decision Date | 2009-10-02 |