Device Classification Name |
Screw, Fixation, Bone
|
510(k) Number |
K113084 |
Device Name |
RENOVIS CANNULATED SCREW SYSTEM |
Applicant |
RENOVIS SURGICAL TECHNOLOGIES, LLC |
200 HOMER AVE. |
ASHLAND,
MA
01721
|
|
Applicant Contact |
DAVID F ROTHKOPF |
Correspondent |
RENOVIS SURGICAL TECHNOLOGIES, LLC |
200 HOMER AVE. |
ASHLAND,
MA
01721
|
|
Correspondent Contact |
DAVID F ROTHKOPF |
Regulation Number | 888.3040
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/18/2011 |
Decision Date | 12/09/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|