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510(k) K160071

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2016
Date Received
January 13, 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

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Other clearances for product code MBB

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  • 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)