DeviceClearance

Product code NKG— Orthopedic

M.U.S.T. MINI Posterior Cervical Screws System

Classification name
Posterior Cervical Screw System
Device class
Class 2
Regulation
21 CFR 888.3075
Advisory panel
Orthopedic
Total cleared
118
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code NKG under 21 CFR 888.3075, via openFDA

Market context for product code NKG

FDA has cleared 118 devices under product code NKG between 2015 and 2026, filed by 62 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NKG

Adverse events under product code NKG

product code NKG
Death
15
Injury
1,090
Malfunction
529
Total
1,634

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

Recent clearances under product code NKG

1–100 of 118

Data sourced from openFDA. This site is unofficial and independent of the FDA.