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510(k) K162974

Biomet Microfixation RibFix Blu Thoracic Fixation System by Biomet Microfixation — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2016
Date Received
October 25, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • K213712 — Pectus Support Bar System (March 11, 2022)
  • K213208 — Twist Drills (December 23, 2021)
  • K202969 — Biomet Microfixation OmniMax MMF System (August 5, 2021)
  • K190576 — WalterLorenz Surgical Assist Arm Scope Holder (June 5, 2019)
  • K163007 — Biomet Microfixation SternaLock 360 Sternal Closure System (November 23, 2016)
  • K161896 — Biomet Microfixation Sternal Closure System (August 2, 2016)

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