Home / 510(k) Clearances / K102401

510(k) K102401

HEMI IMPLANT; MINI HEMI IMPLANT by Vilex, Inc. — Product Code KWD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2011
Date Received
August 24, 2010
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, Inc.

  • K250304 — TITANEX Screw Systems (March 5, 2025)
  • K240475 — Hintermann Series H2 Total Ankle System (December 2, 2024)
  • K243408 — TACTIX Vector Syndesmosis System (November 27, 2024)
  • K233816 — REDEMPTION Charcot Plating System (August 28, 2024)
  • K240035 — TACTIX Vector Syndesmosis System (August 1, 2024)
  • K231343 — Redemption Duo Hindfoot Nail System (January 30, 2024)
  • K231504 — TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System (September 11, 2023)
  • K231493 — NITINEX Memory Compression Staple (August 11, 2023)
  • K230462 — OPTIX H2 Patient Specific Instrument System (July 17, 2023)
  • K230204 — ALPHALOK Plating System (April 25, 2023)

Other clearances for product code KWD

  • K240268 — Accu-Joint Hemi Implant (February 29, 2024)
  • K221220 — Montross Extremity Medical Hemi Implant System (April 19, 2023)
  • K222964 — BioPoly Lesser Toe Hemiarthroplasty Implant (November 22, 2022)
  • 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)
  • K190543 — Cannulated Hemi Implant (May 31, 2019)
  • K161279 — Life Spine Metatarsal Hemi Implant (February 1, 2017)
  • K152454 — HemiCAP MTP Resurfacing Hemi-Arthroplasty System (April 11, 2016)