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510(k) K223199

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2022
Date Received
October 13, 2022
Clearance Type
Special
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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  • K213712 — Pectus Support Bar System (March 11, 2022)
  • K213208 — Twist Drills (December 23, 2021)
  • K202969 — Biomet Microfixation OmniMax MMF System (August 5, 2021)
  • K190576 — WalterLorenz Surgical Assist Arm Scope Holder (June 5, 2019)
  • K162974 — Biomet Microfixation RibFix Blu Thoracic Fixation System (December 9, 2016)
  • K163007 — Biomet Microfixation SternaLock 360 Sternal Closure System (November 23, 2016)
  • K161896 — Biomet Microfixation Sternal Closure System (August 2, 2016)

Other clearances for product code HBE

  • K250815 — Hubly Drill (H100) (November 6, 2025)
  • K252060 — GREEN (October 31, 2025)
  • K252662 — UniBur (September 19, 2025)
  • 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)
  • K213072 — 2.1 x 255mm Drill, 22mm Stop (August 23, 2022)
  • K213208 — Twist Drills (December 23, 2021)