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510(k) K233260

Univers Revers CA Head and Adapter by Arthrex, Inc. — Product Code HSD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2024
Date Received
September 29, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device Class
Class II
Regulation Number
888.3690
Review Panel
OR
Submission Type

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Other clearances for product code HSD

  • K221232 — Univers Revers Humeral Cup Implant (May 19, 2022)
  • K191433 — AGILON® XO Shoulder Replacement System (November 12, 2020)
  • K193122 — Biocore9 Humeral Resurfacing System (May 15, 2020)
  • K173964 — OVOMotion Shoulder Arthroplasty System (April 18, 2018)
  • K161782 — Arthrex Univers Revers Shoulder Prosthesis System (November 21, 2016)
  • K161620 — Anatomical Shoulder Domelock Dome centric (November 1, 2016)
  • K151527 — Arthrex Univers Revers CA Heads and Adapters (April 19, 2016)
  • K142942 — HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System (December 19, 2014)
  • K131298 — EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM (November 26, 2013)
  • K130759 — HUMELOCK II CEMENTLESS SHOULDER SYSTEM (November 9, 2013)