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C-JAWS CERVICAL COMPRESSIVE MINI FRAME

K072040 Class II Special
Decision Date
2007-08-03
Sponsor / Applicant
Medicrea Technologies

Technical Specification

510(k) Submission ID K072040
Product Code KWQ
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.3060
Decision Date 2007-08-03
Clearance Pathway Special

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

C-JAWS CERVICAL COMPRESSIVE MINI FRAME received FDA 510(k) clearance under submission number K072040, sponsored by Medicrea Technologies. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2007-08-03.

Classification & Regulation

This clearance is catalogued under FDA product code KWQ and 21 CFR 888.3060, within the Orthopedic review panel as a Class II device.