Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K063070 |
Device Name |
APERFIX TIBIAL IMPLANT WITH INSERTER |
Applicant |
CAYENNE MEDICAL, INC. |
11234 EL CAMINO REAL |
SUITE 200 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
Floyd Larson |
Correspondent |
CAYENNE MEDICAL, INC. |
11234 EL CAMINO REAL |
SUITE 200 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
Floyd Larson |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 10/06/2006 |
Decision Date | 12/14/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|