Device Classification Name |
fastener, fixation, nondegradable, soft tissue
|
510(k) Number |
K112991 |
Device Name |
MODIFIED ROG SUTURE ANCHOR |
Applicant |
ROG SPORTS MEDICINE, INC. |
80 SHELTON TECHNOLOGY CENTER |
SHELTON,
CT
06484
|
|
Applicant Contact |
CURTIS RAYMOND |
Correspondent |
ROG SPORTS MEDICINE, INC. |
80 SHELTON TECHNOLOGY CENTER |
SHELTON,
CT
06484
|
|
Correspondent Contact |
CURTIS RAYMOND |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 10/06/2011 |
Decision Date | 12/08/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|