Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Medacta International. It received FDA 510(k) clearance on 2016-05-20 under 510(k) 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. The listed applicant is Medacta International. The 510(k) number is K160289.

When did MasterLoc Stem receive FDA 510(k) clearance?

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

Who is the listed applicant for MasterLoc Stem?

The FDA 510(k) record lists Medacta International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MasterLoc Stem?

The FDA product code for MasterLoc Stem is LZO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07616895MFinity BE Pre-market TrialNOT_YET_RECRUITING

Other records listing Medacta International as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261016MSS - Humeral reverse liners extensionK160605MectaLIF Anterior Stand-AloneK153664M.U.S.T. Pedicle Screw System

Related Devices (Code: LZO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbHK252401implaFit® short stemsImplantcast GmbHK253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.

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.

↑