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510(k) K151456

Small Bone Nail Implant by Vilex IN Tennessee, Inc. — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2015
Date Received
June 1, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

Other clearances by Vilex IN Tennessee, Inc.

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  • K190543 — Cannulated Hemi Implant (May 31, 2019)
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  • K151881 — X-Fix Line Additions (March 24, 2016)
  • K150211 — EzFuze Implant System (November 10, 2015)
  • K141937 — TRIDENT FUSION IMPLANT (September 10, 2014)

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