Device Classification Name |
fastener, fixation, nondegradable, soft tissue
|
510(k) Number |
K192428 |
Device Name |
AFX Femoral Implant with Inserter |
Applicant |
Cayenne Medical |
16597 N 92nd Street |
Scottsdale,
AZ
85260
|
|
Applicant Contact |
Shima Hashemian |
Correspondent |
Cayenne Medical |
16597 N 92nd Street |
Scottsdale,
AZ
85260
|
|
Correspondent Contact |
Shima Hashemian |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 09/05/2019 |
Decision Date | 10/05/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|