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510(k) K071704

SLEEVE AND BUTTON SOFT TISSUE DEVICES by Biomet Sports Medicine, Inc. — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2007
Date Received
June 21, 2007
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, Inc.

  • K140908 — JUGGERKNOT MINI SOFT ANCHOR (October 2, 2014)
  • 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)
  • 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)

Other clearances for product code MBI

  • K251750 — Trax EX Anchor (March 12, 2026)
  • K253693 — Strut Suture; No-Tie Button (March 11, 2026)
  • K260405 — FiberTape Button (March 9, 2026)
  • K253538 — TeKBrace Knotless Anchor (March 6, 2026)
  • K254306 — Aevumed FENIX Suture Anchor (March 4, 2026)
  • K254229 — Arthrex Nano FiberTak Suture Anchor (March 2, 2026)
  • K253695 — LigaMend (February 27, 2026)
  • K253763 — Y-Knotless™ Flex Anchors (January 29, 2026)
  • K260004 — Aevumed PROTEKT Suture Anchor (January 28, 2026)
  • K253618 — QuadLock™ Fixation System (January 6, 2026)