Home / 510(k) Clearances / K091688

510(k) K091688

A-GRIX RESORBABLE BONE VOID FILLER by Ag Digital Technology Corp. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2010
Date Received
June 10, 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 Ag Digital Technology Corp.

  • K121453 — A-GRIX TE RESORABLE BONE VOID FILLER (February 5, 2013)
  • K101641 — AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301 (June 16, 2011)
  • K083279 — CALTRIX RESORBABLE BONE VOID FILLER (January 28, 2009)

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)