Atlas FDA

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

FDA 510(k) clearance K213454 · decided 2021-11-23

Clearance details

K-number
K213454
Device name
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
Applicant
Medtronic Powered Surgical Solutions
Decision
Substantially Equivalent
Date received
2021-10-26
Decision date
2021-11-23
Days to decision
28 days
Clearance type
Special
Product code
HBE
Device class
2
Regulation number
882.4310
Medical specialty
Neurology
Advisory committee
Neurology
Location
Fort Worth, TX, 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
Twist Drills (K213208)Biomet Microfixation2021-12-23

Recalls involving this device

No recalls on record reference this clearance.