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510(k) K161273

StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis by Biomet, Inc. — Product Code MBB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2017
Date Received
May 5, 2016
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.

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  • K213287 — StageOne Knee Cement Spacer Molds (September 2, 2022)
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  • K193214 — WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw Syste (November 10, 2020)
  • K193546 — Distal Centralizers (September 25, 2020)
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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)
  • K221968 — StageOne™ Shoulder Cement Spacer Molds (September 15, 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)