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510(k) K090128

TAC-TITE (TM) by Core Essence Orthopaedics, Inc. — Product Code GAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2009
Date Received
January 21, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type

Other clearances by Core Essence Orthopaedics, Inc.

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  • K101126 — PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS (December 2, 2010)
  • K081060 — FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 (December 24, 2008)
  • K071477 — REVERTO 55 AND 37 SHAPE MEMORY STAPLES (August 15, 2007)
  • K071520 — RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X (August 10, 2007)

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