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510(k) K221232

Univers Revers Humeral Cup Implant by Arthrex, Inc. — Product Code HSD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2022
Date Received
April 29, 2022
Clearance Type
Special
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

  • K233260 — Univers Revers CA Head and Adapter (February 12, 2024)
  • 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)