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510(k) K190543

Cannulated Hemi Implant by Vilex IN Tennessee, Inc. — Product Code KWD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2019
Date Received
March 4, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Toe, Hemi-, Phalangeal
Device Class
Class II
Regulation Number
888.3730
Review Panel
OR
Submission Type

Other clearances by Vilex IN Tennessee, Inc.

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  • K150211 — EzFuze Implant System (November 10, 2015)
  • K151456 — Small Bone Nail Implant (October 29, 2015)
  • K141937 — TRIDENT FUSION IMPLANT (September 10, 2014)

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  • K201393 — restor3d MTP Implant (May 25, 2022)
  • K203634 — BioPoly Great Toe Hemiarthroplasty Implant (February 2, 2021)
  • K200951 — Accu-Joint Hemi Implant (December 8, 2020)
  • K190261 — BOSS Toe Fixation System (August 14, 2019)
  • K161279 — Life Spine Metatarsal Hemi Implant (February 1, 2017)
  • K152454 — HemiCAP MTP Resurfacing Hemi-Arthroplasty System (April 11, 2016)
  • K131377 — HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT (November 19, 2013)