Device Classification Name |
Fastener, Fixation, Nondegradable, Soft Tissue
|
510(k) Number |
K180118 |
Device Name |
Arthrex NanoSuture Anchor |
Applicant |
Arthrex Inc. |
1370 Creekside Boulevard |
Naples,
FL
34108 -5553
|
|
Applicant Contact |
Rebecca R. Homan |
Correspondent |
Arthrex Inc. |
1370 Creekside Boulevard |
Naples,
FL
34108 -5553
|
|
Correspondent Contact |
Rebecca R. Homan |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 01/16/2018 |
Decision Date | 02/12/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|