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510(k) K112030

SYNTHES RADIAL HEAD PROSTHESIS SYSTEM by Synthes USA, LLC — Product Code KWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2012
Date Received
July 15, 2011
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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  • K121601 — SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TI (July 6, 2012)
  • K120854 — SYNTHES VA LCP ANKLE TRAUMA SYSTEM (June 18, 2012)
  • K120717 — SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMER (May 8, 2012)
  • K120070 — SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (March 21, 2012)
  • K120083 — SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN) (February 8, 2012)
  • K110592 — 3.7MM/5.0MM DYNAMIC LOCKING SCREW (July 25, 2011)
  • K110125 — 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM (April 21, 2011)
  • K110354 — 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM (March 4, 2011)

Other clearances for product code KWI

  • K233592 — BioPoly Radial Head Implant (March 13, 2024)
  • 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)
  • K092721 — ALIGN RADIAL HEAD SYSTEM (August 3, 2010)