Device Classification Name |
fastener, fixation, nondegradable, soft tissue
|
510(k) Number |
K153667 |
Device Name |
TRUESPAN Meniscal Repair System |
Applicant |
Medos International SARL |
Chemin-Blanc 38 |
Le Locle Neuchatel,
CH
2400
|
|
Applicant Contact |
Kristine Christo |
Correspondent |
Depuy Mitek, a Johnson and Johnson Company |
325 Paramount Drive |
Raynham,
MA
02767
|
|
Correspondent Contact |
Yayoi Fujimaki |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 12/21/2015 |
Decision Date | 03/24/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|