Device Classification Name |
appliance, fixation, nail/blade/plate combination, multiple component
|
510(k) Number |
K110965 |
Device Name |
RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM |
Applicant |
RENOVIS SURGICAL TECHNOLOGIES, LLC |
11234 EL CAMINO REAL |
SUITE 200 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
DAVID J COLLETTE, MD |
Correspondent |
RENOVIS SURGICAL TECHNOLOGIES, LLC |
11234 EL CAMINO REAL |
SUITE 200 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
DAVID J COLLETTE, MD |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 04/06/2011 |
Decision Date | 05/11/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|