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510(k) K203634

BioPoly Great Toe Hemiarthroplasty Implant by BioPoly, LLC — Product Code KWD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 2021
Date Received
December 11, 2020
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 BioPoly, LLC

  • K233592 — BioPoly Radial Head Implant (March 13, 2024)
  • K222964 — BioPoly Lesser Toe Hemiarthroplasty Implant (November 22, 2022)

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)
  • 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)
  • K131377 — HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT (November 19, 2013)