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510(k) K072327

CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON by Regeneration Technologies, Inc. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2007
Date Received
August 20, 2007
Clearance Type
Special
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.

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  • 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)
  • K043420 — OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE (February 10, 2005)

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