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510(k) K233592

BioPoly Radial Head Implant by BioPoly, LLC — Product Code KWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2024
Date Received
November 8, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Elbow, Hemi-, Radial, Polymer
Device Class
Class II
Regulation Number
888.3170
Review Panel
OR
Submission Type

Other clearances by BioPoly, LLC

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  • K203634 — BioPoly Great Toe Hemiarthroplasty Implant (February 2, 2021)

Other clearances for product code KWI

  • K231188 — ALIGN Radial Head System (September 28, 2023)
  • K213563 — DePuy Synthes Radial Head Replacement System (March 18, 2022)
  • K212872 — Avenger Radial Head System (December 17, 2021)
  • K192754 — Avenger Radial Head System (January 7, 2020)
  • K183618 — Revolution Radial Head (May 17, 2019)
  • K172688 — Align Radial Head System (December 22, 2017)
  • K132735 — AXIA RADIAL HEAD SYSTEM (January 7, 2014)
  • K131845 — ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUM (September 30, 2013)
  • K112030 — SYNTHES RADIAL HEAD PROSTHESIS SYSTEM (June 19, 2012)
  • K092721 — ALIGN RADIAL HEAD SYSTEM (August 3, 2010)