EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System— 510(k) K181603

Clearance details

Applicant

K2m, Inc.

Product code

Code NKG

Device class

Class 2

Regulation

21 CFR 888.3075

Advisory panel

Orthopedic

Date received

2018-06-19

Decision date

2018-10-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Leesburg, VA, US

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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 →