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SYNTHES ZERO-P VARIABLE ANGLE (VA)

K112068 Class II Traditional
Decision Date
2011-11-07
Sponsor / Applicant
Synthes Spine Co.Lp

Technical Specification

510(k) Submission ID K112068
Product Code OVE
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.3080
Decision Date 2011-11-07
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

SYNTHES ZERO-P VARIABLE ANGLE (VA) received FDA 510(k) clearance under submission number K112068, sponsored by Synthes Spine Co.Lp. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2011-11-07.

Classification & Regulation

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