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510(k) K253147

FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute FIBERGRAFT BG Matrix Bone Graft Substitute by Prosidyan, Inc. — Product Code MQV

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 22, 2025
Date Received: September 25, 2025
Clearance Type: Special
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.

K251648 — GPS Advanced; GPS Advanced Cannula (June 24, 2025)
K241426 — GPS Advanced; 5 cc GPS Advanced Cannula (July 10, 2024)
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)
K143533 — FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE (March 25, 2015)
K141956 — FIBERGRAFT BG MORSELS (August 13, 2014)

Other clearances for product code MQV

K253524 — Adaptos®Fuse Bone Graft (February 17, 2026)
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)
K250521 — NanoBone® SBX Putty ; NanoBone® QD (April 7, 2025)