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510(k) K213712

Pectus Support Bar System by Biomet Microfixation — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2022
Date Received
November 24, 2021
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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  • K190576 — WalterLorenz Surgical Assist Arm Scope Holder (June 5, 2019)
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  • K163007 — Biomet Microfixation SternaLock 360 Sternal Closure System (November 23, 2016)
  • K161896 — Biomet Microfixation Sternal Closure System (August 2, 2016)

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