510(k) K223199

Device: 2.1 x 255mm Drill, 22mm Stop
Applicant: Biomet Microfixation
510(k) number: K223199
Product code: HBE
Decision: Substantially Equivalent (SESE)
Decision date: 2022-11-15
Date received: 2022-10-13
Regulation: 882.4310
Classification name: Drills, Burrs, Trephines & Accessories (Simple, Powered)
Medical specialty: Neurology
Review panel: Neurology
Device class: 2
Clearance type: Special
Statement or summary: Summary
Third party reviewed: No

Related Records

Applicant Contact

Contact: Jay Sharma
Address: 1520 Tradeport Dr. Jacksonville FL US 32218 32218

FDA Registration Numbers

3030956508
9614948
3006128100
2029275
1526611
3028006458
9610612
3010041499
3014334038
3026776
1835444
3036773433
2183456
3002807314
8010177
8043933
3033509898
2648623
3005562917
3012607373
3005067367
3007997036
1047843
3018094310
3003933619
2011171
9680741
3009973505
1048735
8010516
3008868758
3014725904
2133641
3010097171
3040335671
3001592626
3010363503
1032347
1824199
8043792
1836357
3014479313
3005282635
1220477
3008812560
1287329
1045834
8031010
2025102
8010468
8044015
3009417901
3015440604
3005677016
2647346
1825034
3007031059
3011300255
2953359
3015453963
3009380063
8030607
1226544
3007539489
1649518
1833986
1828288
2134947
1220724
3016438694
3023852420
1045254
1061124
1526534
3025603301
3009732568
3015967359
3009970070
3016678045
3010173425

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code HBE

510(k)	Device	Applicant	Decision date
K253627	Surgify 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 OY	2026-03-26
K250815	Hubly Drill (H100)	Hubly, Inc.	2025-11-06
K252060	GREEN	Phasor Health, LLC	2025-10-31
K252662	UniBur	Nakanishi, Inc.	2025-09-19
K251433	Surgify 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 OY	2025-06-04
K250380	Surgify 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 OY	2025-03-13
K250374	iBur 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 R	Stryker Instruments	2025-03-11
K232684	Surgify Halo	Surgify Medical OY	2023-11-29
K230619	Hubly Electric Drill (H100)	Hubly, Inc.	2023-05-04
K213072	2.1 x 255mm Drill, 22mm Stop	Biomet Micofixation	2022-08-23
K213208	Twist Drills	Biomet Microfixation	2021-12-23
K213454	Midas 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 7.5mm	Medtronic Powered Surgical Solutions	2021-11-23
K202120	P300 Attachment	Nakanishi, Inc.	2021-10-22
K203739	ELAN 4 Electro Motor System	Aesculap, Inc.	2021-08-24
K210377	Stryker iBur hubs and cutting accessories	Stryker Corporation	2021-06-30