Device Classification Name |
fastener, fixation, nondegradable, soft tissue
|
510(k) Number |
K112876 |
Device Name |
CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5 |
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 |
|
Subsequent Product Code |
|
Date Received | 09/30/2011 |
Decision Date | 12/15/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|