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FDA 510(k)

MasterLoc Stem

K-Number: K160289 · 2016-05-20

ApplicantMedacta International
Decision Date2016-05-20
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MasterLoc Stem is a medical device manufactured by Medacta International. It received FDA 510(k) clearance on 2016-05-20 under approval number K160289. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MasterLoc Stem?

MasterLoc Stem is a medical device that received FDA 510(k) clearance on 2016-05-20. It is manufactured by Medacta International. The 510(k) number is K160289.

When was MasterLoc Stem approved by the FDA?

MasterLoc Stem received FDA 510(k) clearance on 2016-05-20, under approval number K160289.

What company makes MasterLoc Stem?

MasterLoc Stem is manufactured by Medacta International.

What is the FDA product code for MasterLoc Stem?

The FDA product code for MasterLoc Stem is LZO.

Other Devices by Medacta International

K160605MectaLIF Anterior Stand-Alone K153664M.U.S.T. Pedicle Screw System

Related Devices (Code: LZO)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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