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510(k) K140069

LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0 by Merete Medical GmbH — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2014
Date Received
January 13, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • K151762 — PediatrOS RigidTack/FlexTack (December 28, 2015)
  • K142451 — OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod Syste (February 9, 2015)
  • K141377 — BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD (November 21, 2014)
  • K132226 — METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT (August 9, 2013)
  • K123619 — INTRABLOCK BIOBALL HIP SYSTEM (IBS) (May 24, 2013)
  • K130400 — MERETEC CS, CORTICAL SCREWS (April 5, 2013)
  • K120787 — MERETE LOCKING BONE PLATE SYSTEM III (November 27, 2012)
  • K120978 — OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR (May 2, 2012)

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