Device Classification Name |
fastener, fixation, nondegradable, soft tissue
|
510(k) Number |
K143392 |
Device Name |
Quattro Bolt Tenodesis Screw |
Applicant |
CAYENNE MEDICAL, INC |
16597 N. 92ND ST |
SCOTTSDALE,
AZ
85260
|
|
Applicant Contact |
Shima Hashemian |
Correspondent |
CAYENNE MEDICAL, INC |
16597 N. 92ND ST |
SCOTTSDALE,
AZ
85260
|
|
Correspondent Contact |
Shima Hashemian |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 11/26/2014 |
Decision Date | 01/23/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|