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510(k) K201353

CenterMed Patient Matched Assisted Surgical Planning (ASP) System by Centermed, Inc. — Product Code DZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2021
Date Received
May 21, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Driver, Wire, And Bone Drill, Manual
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type

Other clearances by Centermed, Inc.

  • K211614 — CenterMed Patient Matched Assisted Surgical Planning (ASP) System (August 4, 2022)

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