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510(k) K173008

SCS 17-01 by Anika Therapeutics, Inc. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 2017
Date Received
September 27, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Calcium Compound
Device Class
Class II
Regulation Number
888.3045
Review Panel
OR
Submission Type

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  • K222487 — Anika Tissue Tack Fixation System (May 8, 2023)
  • K223915 — Tactoset (March 29, 2023)
  • K212083 — Tactoset Injectable Bone Substitute (August 31, 2021)
  • K190956 — SCS 17-01 (January 30, 2020)

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