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510(k) K043420

OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE by Regeneration Technologies, Inc. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2005
Date Received
December 13, 2004
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 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)
  • K060180 — BIOSET XC (September 6, 2006)
  • 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)

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