Home / 510(k) Clearances / K050642

510(k) K050642

ORTHOBLAST II PUTTY AND PASTE by Isotis Orthobiologics, Inc. — Product Code MBP

K050642 is an FDA 510(k) premarket notification submitted by Isotis Orthobiologics, Inc. for the device "ORTHOBLAST II PUTTY AND PASTE". The FDA issued a decision of Substantially Equivalent on December 5, 2005. The device falls under product code MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)), a Class II device regulated under 21 CFR 888.3045. Isotis Orthobiologics, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2005
Date Received
March 11, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
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)
  • K070751 — ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY (October 15, 2007)
  • 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 MBP

  • K242799 — PliaFX Flo (November 21, 2024)
  • K143547 — Vivorte Trabexus EB (January 14, 2015)
  • K130703 — VIVORTE BVF (September 12, 2013)
  • K130498 — OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY (May 31, 2013)
  • K122513 — CLEARED UNDER GRAFTON II EDBM (March 6, 2013)
  • K113728 — SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY (November 15, 2012)
  • K103742 — ACCELL EVO3 (FORMERLY ACCELL A2I) (March 17, 2011)
  • K091193 — ACCELL EVO3C (August 10, 2009)
  • K080399 — DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE (October 10, 2008)
  • K081817 — ACCELL TBM-R (September 24, 2008)

FDA data resources