Device Classification Name |
Fastener, Fixation, Nondegradable, Soft Tissue
|
510(k) Number |
K133036 |
Device Name |
APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS |
Applicant |
AMENDIA INC. |
11821 BRAMBLE COVE DRIVE |
FT. MYERS,
FL
33905
|
|
Applicant Contact |
RICH JANSEN |
Correspondent |
AMENDIA INC. |
11821 BRAMBLE COVE DRIVE |
FT. MYERS,
FL
33905
|
|
Correspondent Contact |
RICH JANSEN |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 09/26/2013 |
Decision Date | 03/06/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|