Device Classification Name |
fastener, fixation, nondegradable, soft tissue
|
510(k) Number |
K161033 |
Device Name |
AFX™ Femoral Implant With Inserter |
Applicant |
CAYENNE MEDICAL, INC. |
16597 N 92ND STREET |
SCOTTSDALE,
AZ
85260
|
|
Applicant Contact |
SHIMA HASHEMIAN |
Correspondent |
CAYENNE MEDICAL, INC. |
16597 N 92ND STREET |
SCOTTSDALE,
AZ
85260
|
|
Correspondent Contact |
SHIMA HASHEMIAN |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 04/13/2016 |
Decision Date | 08/03/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|