Home / 510(k) Clearances / K152187

510(k) K152187

MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws by Merete Medical GmbH — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2016
Date Received
August 5, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Merete Medical GmbH

  • K160548 — MC-Subtalar(TM) II (April 29, 2016)
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  • 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)
  • 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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