Device Classification Name |
Fastener, Fixation, Nondegradable, Soft Tissue
|
510(k) Number |
K120841 |
Device Name |
APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR |
Applicant |
KFX MEDICAL |
5845 Avenida Encinas, Suite 128 |
CARLSBAD,
CA
92008
|
|
Applicant Contact |
GAYLE HIROTA |
Correspondent |
KFX MEDICAL |
5845 Avenida Encinas, Suite 128 |
CARLSBAD,
CA
92008
|
|
Correspondent Contact |
GAYLE HIROTA |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 03/20/2012 |
Decision Date | 06/07/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|