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510(k) K072922

3S HEMI TOE by Trilliant Surgical, Ltd. — Product Code KWD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 2007
Date Received
October 15, 2007
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

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  • K172405 — SNIPER STAPLE SYSTEM, NON-STERILE (December 11, 2017)
  • K172178 — Minimally Invasive Bunion Plating System (November 16, 2017)
  • K162354 — Sniper Staple System (April 20, 2017)
  • K160177 — Gridlock Ankle Plating System (April 22, 2016)
  • K153338 — Tiger Cannulated Screw System (January 14, 2016)
  • K130964 — GRIDLOCK PLATING SYSTEM (May 8, 2013)
  • K123525 — GRIDLOCK PLATING SYSTEM (February 15, 2013)

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)