OWI

Bone Fixation Cerclage, Sublaminar

Product code

OWI

Device name

Bone Fixation Cerclage, Sublaminar

Device class

Class 2

21 CFR

21 CFR 888.3010

Medical specialty

Orthopedic

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (last 3 years)

2

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification definition

Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.

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

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-05-27.

2 summaries are archived here for direct download.