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510(k) K151762

PediatrOS RigidTack/FlexTack by Merete Medical GmbH — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 2015
Date Received
June 29, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K141377 — BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD (November 21, 2014)
  • K140069 — LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3. (April 7, 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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