Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
|
510(k) Number |
K132312 |
Device Name |
RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM |
Applicant |
RENOVIS SURGICAL TECHNOLOGIES, LLC |
200 Homer Ave |
Ashland,
MA
01721
|
|
Applicant Contact |
Sharyn Orton, Ph.D. |
Correspondent |
RENOVIS SURGICAL TECHNOLOGIES, LLC |
200 Homer Ave |
Ashland,
MA
01721
|
|
Correspondent Contact |
Sharyn Orton, Ph.D. |
Regulation Number | 888.3358
|
Classification Product Code |
|
Date Received | 07/25/2013 |
Decision Date | 04/11/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|