Atlas FDA

Twist Drills

FDA 510(k) clearance K213208 · decided 2021-12-23

Clearance details

K-number
K213208
Device name
Twist Drills
Applicant
Biomet Microfixation
Decision
Substantially Equivalent
Date received
2021-09-29
Decision date
2021-12-23
Days to decision
85 days
Clearance type
Traditional
Product code
HBE
Device class
2
Regulation number
882.4310
Medical specialty
Neurology
Advisory committee
Neurology
Location
Jacksonville, FL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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) (K253627)Surgify Medical OY2026-03-26
Hubly Drill (H100) (K250815)Hubly, Inc.2025-11-06
GREEN (K252060)Phasor Health, LLC2025-10-31
UniBur (K252662)Nakanishi, Inc.2025-09-19
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) (K251433)Surgify Medical OY2025-06-04
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) (K250380)Surgify Medical OY2025-03-13
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 (K250374)Stryker Instruments2025-03-11
Surgify Halo (K232684)Surgify Medical OY2023-11-29
Hubly Electric Drill (H100) (K230619)Hubly, Inc.2023-05-04
2.1 x 255mm Drill, 22mm Stop (K223199)Biomet Microfixation2022-11-15
2.1 x 255mm Drill, 22mm Stop (K213072)Biomet Micofixation2022-08-23
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 (K213454)Medtronic Powered Surgical Solutions2021-11-23

Recalls involving this device

No recalls on record reference this clearance.