Yukon OCT Spinal System— 510(k) K193129

Clearance details

Applicant

K2m, Inc.

Product code

Code NKG

Device class

Class 2

Regulation

21 CFR 888.3075

Advisory panel

Orthopedic

Date received

2019-11-12

Decision date

2020-02-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Leesburg, VA, US

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• K202528 — Cannulated Power Driver Attachment2020-10-26

Death

15

Injury

1,090

Malfunction

529

Total

1,634

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0520-2021 — Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides counter rotation to reduce the torque applied to the anatomy when the size 15 Torque limiting shaft (the shaft is used to tighten the Yukon Set Screw to the specified torque.Class II·Terminated·K2M, Inc·20201103

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K193129.