Device Classification Name |
Fastener, Fixation, Nondegradable, Soft Tissue
|
510(k) Number |
K122463 |
Device Name |
APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W |
Applicant |
CAYENNE MEDICAL, INC. |
16597 N. 92ND STREET |
SUITE 101 |
SCOTTSDALE,
AZ
85260
|
|
Applicant Contact |
KERESHMEH SHAHRIARI |
Correspondent |
CAYENNE MEDICAL, INC. |
16597 N. 92ND STREET |
SUITE 101 |
SCOTTSDALE,
AZ
85260
|
|
Correspondent Contact |
KERESHMEH SHAHRIARI |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 08/13/2012 |
Decision Date | 10/11/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|