Device Classification Name |
filler, bone void, calcium compound
|
510(k) Number |
K173008 |
Device Name |
SCS 17-01 |
Applicant |
Anika Therapeutics, Inc. |
32 Wiggins Avenue |
Bedford,
MA
01730
|
|
Applicant Contact |
Steven Chartier |
Correspondent |
Musculoskeletal Clinical Regulatory Advisers, LLC |
32 Wiggins Avenue |
Bedford,
MA
01730
|
|
Correspondent Contact |
Steven Chartier |
Regulation Number | 888.3045
|
Classification Product Code |
|
Date Received | 09/27/2017 |
Decision Date | 12/26/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|