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510(k) K151019

SternaLock® 360 Sternal Closure System by Biomet Microfixation — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2015
Date Received
April 16, 2015
Clearance Type
Traditional
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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  • K162974 — Biomet Microfixation RibFix Blu Thoracic Fixation System (December 9, 2016)
  • K163007 — Biomet Microfixation SternaLock 360 Sternal Closure System (November 23, 2016)

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