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510(k) K123485

JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF by Biomet Sports Medicine — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2013
Date Received
November 13, 2012
Clearance Type
Traditional
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

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  • K110879 — BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR (August 19, 2011)
  • K111564 — MAXFIRE MARXMEN MENISCAL REPAIR DEVICE (June 16, 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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