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510(k) K210377

Stryker iBur hubs and cutting accessories by Stryker Corporation — Product Code HBE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2021
Date Received
February 9, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drills, Burrs, Trephines & Accessories (Simple, Powered)
Device Class
Class II
Regulation Number
882.4310
Review Panel
NE
Submission Type

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Other clearances for product code HBE

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  • K232684 — Surgify Halo (November 29, 2023)
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  • K223199 — 2.1 x 255mm Drill, 22mm Stop (November 15, 2022)
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