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510(k) K190956

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2020
Date Received
April 11, 2019
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

Other clearances by Anika Therapeutics, Inc.

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  • K231968 — Tactoset® Injectable Bone Substitute (December 20, 2023)
  • K223538 — Integrity Implant (August 17, 2023)
  • K223860 — Integrity™ Bone Staple Fixation System (May 22, 2023)
  • K222487 — Anika Tissue Tack Fixation System (May 8, 2023)
  • K223915 — Tactoset (March 29, 2023)
  • K212083 — Tactoset Injectable Bone Substitute (August 31, 2021)
  • K173008 — SCS 17-01 (December 26, 2017)

Other clearances for product code MQV

  • K253524 — Adaptos®Fuse Bone Graft (February 17, 2026)
  • K253147 — FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft S (October 22, 2025)
  • K251522 — Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ (October 13, 2025)
  • K252085 — Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix (September 30, 2025)
  • K251556 — Device 300423 Granules (July 17, 2025)
  • K251720 — OsteoFlo HydroFiber (July 2, 2025)
  • K251193 — Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft (June 12, 2025)
  • K243949 — OsteoFlo HydroFiber (May 28, 2025)
  • K243474 — MagnetOs MIS (May 23, 2025)
  • K250141 — Synthecure Synthetic Calcium Sulfate (May 16, 2025)