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510(k) K103145

HAMMERLOC TM TIBIAL FIXATION DEVICE by Biomet Sports Medicine — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2011
Date Received
October 25, 2010
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

Other clearances by Biomet Sports Medicine

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  • K122437 — NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS (October 18, 2013)
  • 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)
  • K111564 — MAXFIRE MARXMEN MENISCAL REPAIR DEVICE (June 16, 2011)
  • K110039 — BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM (May 3, 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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