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510(k) K213208

Twist Drills by Biomet Microfixation — Product Code HBE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2021
Date Received
September 29, 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 Microfixation

  • K241709 — Pectus Blu Support Bar System (September 19, 2024)
  • K223199 — 2.1 x 255mm Drill, 22mm Stop (November 15, 2022)
  • K212782 — SternaLock Sternal Closure System (May 17, 2022)
  • K212608 — RibFix Blu Thoracic Fixation System (April 22, 2022)
  • K213712 — Pectus Support Bar System (March 11, 2022)
  • 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)
  • K223199 — 2.1 x 255mm Drill, 22mm Stop (November 15, 2022)
  • K213072 — 2.1 x 255mm Drill, 22mm Stop (August 23, 2022)