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SCULPTOR ROBOTIC GUIDANCE ARM (RGA)

K121765 Class II Traditional
Decision Date
2013-01-11
Sponsor / Applicant
Stanmore Implants Worldwide , Ltd.

Technical Specification

510(k) Submission ID K121765
Product Code OLO
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.4560
Decision Date 2013-01-11
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

SCULPTOR ROBOTIC GUIDANCE ARM (RGA) received FDA 510(k) clearance under submission number K121765, sponsored by Stanmore Implants Worldwide , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2013-01-11.

Classification & Regulation

This clearance is catalogued under FDA product code OLO and 21 CFR 882.4560, within the Neurology review panel as a Class II device.