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510(k) K131683

HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM) by Depuy Mitek, Inc., A Johnson and Johnson Company — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2013
Date Received
June 10, 2013
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 Depuy Mitek, Inc., A Johnson and Johnson Company

  • K123668 — ORTHOCORD (February 26, 2013)
  • K122123 — 6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCR (October 2, 2012)

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