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510(k) K102777

TWISTCUT ENDOSORB SCREWS by Merete Medical GmbH — Product Code JDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2010
Date Received
September 24, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Threaded
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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  • 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)

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