The following data is part of a premarket notification filed by Renovis Surgical Technologies, Llc with the FDA for Renovis T 710 Large External Fixation System.
| Device ID | K110965 |
| 510k Number | K110965 |
| Device Name: | RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | RENOVIS SURGICAL TECHNOLOGIES, LLC 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Contact | David J Collette, Md |
| Correspondent | David J Collette, Md RENOVIS SURGICAL TECHNOLOGIES, LLC 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-06 |
| Decision Date | 2011-05-11 |
| Summary: | summary |