Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K083607 |
Device Name |
APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM |
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 | 12/05/2008 |
Decision Date | 03/04/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|