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 |