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510(k) K071477

REVERTO 55 AND 37 SHAPE MEMORY STAPLES by Core Essence Orthopaedics, LLC — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2007
Date Received
May 29, 2007
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

Other clearances by Core Essence Orthopaedics, LLC

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  • K090128 — TAC-TITE (TM) (March 19, 2009)
  • K081060 — FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 (December 24, 2008)
  • K071520 — RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X (August 10, 2007)

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