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510(k) K143533

FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE by Prosidyan, Inc. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2015
Date Received
December 12, 2014
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 Prosidyan, Inc.

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  • K213803 — FIBERGRAFT Aeridyan Matrix Bone Graft Substitute (August 23, 2022)
  • K182670 — FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute (December 20, 2018)
  • K180080 — FIBERGRAFT BG Matrix Bone Graft Substitute (April 6, 2018)
  • K171284 — FIBERGRAFT BG Matrix Bone Graft Substitute (June 30, 2017)
  • K170306 — FIBERGRAFT BG Putty Bone Graft Substitute (May 24, 2017)
  • K151154 — FIBERGRAFT BG Morsels (November 10, 2015)
  • K141956 — FIBERGRAFT BG MORSELS (August 13, 2014)

Other clearances for product code MQV

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  • 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)