Home / 510(k) Clearances / K060180

510(k) K060180

BIOSET XC by Regeneration Technologies, Inc. — Product Code MBP

K060180 is an FDA 510(k) premarket notification submitted by Regeneration Technologies, Inc. for the device "BIOSET XC". The FDA issued a decision of Substantially Equivalent on September 6, 2006. 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. Regeneration Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2006
Date Received
January 23, 2006
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 Regeneration Technologies, Inc.

  • K080418 — REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIP (April 30, 2008)
  • K072238 — BIOSET XCH (January 25, 2008)
  • K072327 — CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON (October 24, 2007)
  • K063584 — STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID (May 9, 2007)
  • K060253 — STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST. (February 23, 2006)
  • K052405 — STERLING INTERFERENC SCREW HT (November 16, 2005)
  • K051615 — STERLING CANCELLOUS CHIPS; STERLING CANCELLOUS CUBES (August 15, 2005)
  • K050767 — STERLING INTERFERENCE SCREW ST (June 9, 2005)
  • K043421 — OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC (February 16, 2005)
  • K043420 — OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE (February 10, 2005)

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