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4-WEB ALIF SPINAL TRUSS SYSTEM (STS)

K112316 Class II Special
Decision Date
2011-12-14
Sponsor / Applicant
4-Web, Inc.

Technical Specification

510(k) Submission ID K112316
Product Code MAX
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.3080
Decision Date 2011-12-14
Clearance Pathway Special

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

4-WEB ALIF SPINAL TRUSS SYSTEM (STS) received FDA 510(k) clearance under submission number K112316, sponsored by 4-Web, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2011-12-14.

Classification & Regulation

This clearance is catalogued under FDA product code MAX and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.