Device Classification Name |
fastener, fixation, biodegradable, soft tissue
|
510(k) Number |
K173859 |
Device Name |
HEALIX ADVANCE Anchor with DYNACORD Suture |
Applicant |
Medos International SARL |
Chemin-Blanc 38, Case Postale |
Le Locle,
CH
CH 2400
|
|
Applicant Contact |
Tatyana Tatyana Korsunsky |
Correspondent |
DePuy Mitek, a Johnson & Johnson company |
325 Paramount Drive |
Raynham,
MA
02767
|
|
Correspondent Contact |
Tatyana Korsunsky |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/20/2017 |
Decision Date | 04/11/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|