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510(k) K173301

BioSphere MIS Putty (BioSphere MIS) by Synergy Biomedical, LLC — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2018
Date Received
October 17, 2017
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 Synergy Biomedical, LLC

  • K241167 — BioSphere Putty; BioSphere MIS Putty (December 20, 2024)
  • K173424 — BioSphere Flex (September 12, 2018)
  • K140844 — BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC (July 16, 2014)
  • K122868 — BIOSPHERE BIOACTIVE BONE GRAFT PUTTY (April 19, 2013)

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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)