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510(k) K142828

osteoSPAN Morpheus by Biogennix — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2015
Date Received
September 30, 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 Biogennix

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  • K193168 — Agilon Moldable (February 13, 2020)
  • K190371 — Morpheus-C (August 9, 2019)
  • K181337 — Sypher Spacer System (September 18, 2018)
  • K141798 — SYPHER SPACER SYSTEM (February 19, 2015)
  • K132377 — OSTEOSPAN MORPHEUS (May 20, 2014)
  • K093342 — BIOGENNIX RPC (July 29, 2010)

Other clearances for product code MQV

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  • 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)