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510(k) K110039

BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM by Biomet Sports Medicine — Product Code JDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2011
Date Received
January 6, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cerclage, Fixation
Device Class
Class II
Regulation Number
888.3010
Review Panel
OR
Submission Type

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  • K083070 — TOGGLELOC SYSTEM (December 16, 2008)
  • K071816 — HARPOON SUTURE ANCHOR (September 20, 2007)
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