Home / 510(k) Clearances / K093342

510(k) K093342

BIOGENNIX RPC by Biogennix, LLC — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2010
Date Received
October 26, 2009
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, LLC

  • K240621 — Morpheus® Moldable; Agilon® Moldable (April 30, 2024)
  • K193487 — Agilon Strip (March 30, 2020)
  • 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)
  • K142828 — osteoSPAN Morpheus (January 15, 2015)
  • K132377 — OSTEOSPAN MORPHEUS (May 20, 2014)

Other clearances for product code MQV

  • K253524 — Adaptos®Fuse Bone Graft (February 17, 2026)
  • 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)