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510(k) K213563

DePuy Synthes Radial Head Replacement System by DePuy Synthes — Product Code KWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2022
Date Received
November 9, 2021
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

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Other clearances for product code KWI

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  • K231188 — ALIGN Radial Head System (September 28, 2023)
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  • 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)