Device Classification Name |
fastener, fixation, biodegradable, soft tissue
|
510(k) Number |
K133794 |
Device Name |
4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 |
Applicant |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767
|
|
Applicant Contact |
TATYANA KORSUNSKY |
Correspondent |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767
|
|
Correspondent Contact |
TATYANA KORSUNSKY |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/13/2013 |
Decision Date | 02/04/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|