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510(k) K173424

BioSphere Flex by Synergy Biomedical — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2018
Date Received
November 1, 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

Other clearances by Synergy Biomedical

  • K241167 — BioSphere Putty; BioSphere MIS Putty (December 20, 2024)
  • K173301 — BioSphere MIS Putty (BioSphere MIS) (January 19, 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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  • K251556 — Device 300423 Granules (July 17, 2025)
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  • K251193 — Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft (June 12, 2025)
  • K243949 — OsteoFlo HydroFiber (May 28, 2025)
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  • K250141 — Synthecure Synthetic Calcium Sulfate (May 16, 2025)