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510(k) K111564

MAXFIRE MARXMEN MENISCAL REPAIR DEVICE by Biomet Sports Medicine — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2011
Date Received
June 6, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Biomet Sports Medicine

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  • K123485 — JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT (March 18, 2013)
  • K110879 — BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR (August 19, 2011)
  • K110039 — BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM (May 3, 2011)
  • K103145 — HAMMERLOC TM TIBIAL FIXATION DEVICE (February 9, 2011)
  • K101063 — SLEEVE WITH ZIPLOOP FIXATION DEVICES (June 23, 2010)
  • K083070 — TOGGLELOC SYSTEM (December 16, 2008)
  • K071816 — HARPOON SUTURE ANCHOR (September 20, 2007)
  • K071704 — SLEEVE AND BUTTON SOFT TISSUE DEVICES (September 17, 2007)

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