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510(k) K221968

StageOne™ Shoulder Cement Spacer Molds by Biomet, Inc. — Product Code MBB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2022
Date Received
July 5, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Cement, Antibiotic
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type

Other clearances by Biomet, Inc.

  • K241014 — Biomet Kirschner Wires (K-Wires) (May 22, 2024)
  • K222760 — StageOne™ Select Hip Cement Spacer Molds (December 28, 2022)
  • K213287 — StageOne Knee Cement Spacer Molds (September 2, 2022)
  • K212431 — Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve (February 7, 2022)
  • K212435 — Comprehensive Humeral Fracture Positioning Sleeves (December 10, 2021)
  • K210192 — A.L.P.S. Clavicle Plating System (February 19, 2021)
  • K193214 — WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw Syste (November 10, 2020)
  • K193546 — Distal Centralizers (September 25, 2020)
  • K193373 — Comprehensive® Reverse Shoulder (April 15, 2020)
  • K193402 — ALLthread PEEK Suture Anchor (March 5, 2020)

Other clearances for product code MBB

  • K252443 — SpaceFix Shoulder Spacer (September 15, 2025)
  • K242216 — GENTAFIX® (1, 3, 3MV) (December 18, 2024)
  • K240856 — Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds (November 20, 2024)
  • K222760 — StageOne™ Select Hip Cement Spacer Molds (December 28, 2022)
  • K213287 — StageOne Knee Cement Spacer Molds (September 2, 2022)
  • K202338 — SpaceFlex Shoulder (February 17, 2021)
  • K201960 — SpaceFlex Knee - 80mm Size (August 13, 2020)
  • K192041 — G21 SpaceFlex Hip (October 29, 2019)
  • K190216 — SpaceFlex Knee (June 9, 2019)
  • K161273 — StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis (January 25, 2017)