FDA.report

510(k) K213072

Device
2.1 x 255mm Drill, 22mm Stop
Applicant
Biomet Micofixation
510(k) number
K213072
Product code
HBE
Decision
Substantially Equivalent (SESE)
Decision date
2022-08-23
Date received
2021-09-23
Regulation
882.4310
Classification name
Drills, Burrs, Trephines & Accessories (Simple, Powered)
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Mark Wladkowski
Address
1520 Tradeport Dr. Jacksonville FL US 32218 32218

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code HBE

510(k)DeviceApplicantDecision date
K253627Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2)Surgify Medical OY2026-03-26
K250815Hubly Drill (H100)Hubly, Inc.2025-11-06
K252060GREENPhasor Health, LLC2025-10-31
K252662UniBurNakanishi, Inc.2025-09-19
K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1)Surgify Medical OY2025-06-04
K250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)Surgify Medical OY2025-03-13
K250374iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond RStryker Instruments2025-03-11
K232684Surgify HaloSurgify Medical OY2023-11-29
K230619Hubly Electric Drill (H100)Hubly, Inc.2023-05-04
K2231992.1 x 255mm Drill, 22mm StopBiomet Microfixation2022-11-15
K213208Twist DrillsBiomet Microfixation2021-12-23
K213454Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mmMedtronic Powered Surgical Solutions2021-11-23
K202120P300 AttachmentNakanishi, Inc.2021-10-22
K203739ELAN 4 Electro Motor SystemAesculap, Inc.2021-08-24
K210377Stryker iBur hubs and cutting accessoriesStryker Corporation2021-06-30