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510(k) K213072

2.1 x 255mm Drill, 22mm Stop by Biomet Micofixation — Product Code HBE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2022
Date Received
September 23, 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

Other clearances by Biomet Micofixation

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  • K203474 — Biomet Microfixation RibFix Advantage System (January 28, 2021)

Other clearances for product code HBE

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  • K252060 — GREEN (October 31, 2025)
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  • K251433 — Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070 (June 4, 2025)
  • K250380 — Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.0 (March 13, 2025)
  • K250374 — iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision (March 11, 2025)
  • K232684 — Surgify Halo (November 29, 2023)
  • K230619 — Hubly Electric Drill (H100) (May 4, 2023)
  • K223199 — 2.1 x 255mm Drill, 22mm Stop (November 15, 2022)
  • K213208 — Twist Drills (December 23, 2021)