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510(k) K141937

TRIDENT FUSION IMPLANT by Vilex IN Tennessee, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2014
Date Received
July 17, 2014
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 Vilex IN Tennessee, Inc.

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  • K151881 — X-Fix Line Additions (March 24, 2016)
  • K150211 — EzFuze Implant System (November 10, 2015)
  • K151456 — Small Bone Nail Implant (October 29, 2015)

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