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First Ray Internal Bone Staple System

K153622 Class II Traditional
Decision Date
2016-04-08
Sponsor / Applicant
First Ray, LLC

Technical Specification

510(k) Submission ID K153622
Product Code JDR
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.3030
Decision Date 2016-04-08
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

First Ray Internal Bone Staple System received FDA 510(k) clearance under submission number K153622, sponsored by First Ray, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2016-04-08.

Classification & Regulation

This clearance is catalogued under FDA product code JDR and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.