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510(k) K122123

6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED by Depuy Mitek, Inc., A Johnson and Johnson Company — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2012
Date Received
July 18, 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

Other clearances by Depuy Mitek, Inc., A Johnson and Johnson Company

  • K131683 — HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM) (June 27, 2013)
  • K123668 — ORTHOCORD (February 26, 2013)

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