510(k) clearance

OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts

FDA 510(k) source

510(k) number

K263116

Applicant

OsteoCentric Technologies

Decision date

Oct 2, 2026

Date received

Sep 4, 2026

Decision

Substantially Equivalent

Clearance type

Special

Product code

HWC

Device type

Screw, Fixation, Bone

Device class

Class II

Regulation

21 CFR 888.3040

Advisory committee

Orthopedic

Statement or summary

Summary

Third party

N

Location

Logan, UT, US