Home / 510(k) Clearances / K070751

510(k) K070751

ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY by Isotis Orthobiologics, Inc. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2007
Date Received
March 19, 2007
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 Isotis Orthobiologics, Inc.

  • K091193 — ACCELL EVO3C (August 10, 2009)
  • K081817 — ACCELL TBM-R (September 24, 2008)
  • K050642 — ORTHOBLAST II PUTTY AND PASTE (December 5, 2005)
  • K052098 — CONNEXUS, .5CC, MODEL 023000-005 (September 7, 2005)
  • K043573 — DYNAGRAFT II DENTAL (July 29, 2005)
  • K050690 — CONNEXUS (July 7, 2005)
  • K040419 — DYNAGRAFT II (March 25, 2005)
  • K042706 — OSSATURA DENTAL (October 20, 2004)
  • K041991 — ASPIREX - BONE MARROW ASPIRATE KIT (September 16, 2004)

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)