NKG

Posterior Cervical Screw System

Product code

NKG

Device name

Posterior Cervical Screw System

Device class

Class 2

21 CFR

21 CFR 888.3075

Medical specialty

Orthopedic

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (last 3 years)

16

Summaries archived here

14 (direct download)

510(k) clearances (all years, FDA)

118 (all years; only the last 3 years are listed here)

FDA classification definition

Posterior cervical screw systems are intended for use in fusion procedures of the cervical spine and/or craniocervical junction and/or cervicothoracic junction for: 1) spinal fractures and dislocations; 2) deformities; 3) instabilities; 4) failed previous fusions; 5) tumors; 6) inflammatory disorders; 7) spinal degeneration, 8) facet degeneration with instability; and 9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to stabilize the spine in the absence of fusion for a limited time period in patients with tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (16)

Last three years. Most recent: 2026-06-02.

14 summaries are archived here for direct download.