MasterLoc Extension
K-Number: K191145 · 2019-05-30
ApplicantMedacta International S.A.
Decision Date2019-05-30
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
MasterLoc Extension is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2019-05-30 under approval number K191145. 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 Extension?
MasterLoc Extension is a medical device that received FDA 510(k) clearance on 2019-05-30. It is manufactured by Medacta International S.A.. The 510(k) number is K191145.
When was MasterLoc Extension approved by the FDA?
MasterLoc Extension received FDA 510(k) clearance on 2019-05-30, under approval number K191145.
What company makes MasterLoc Extension?
MasterLoc Extension is manufactured by Medacta International S.A..
What is the FDA product code for MasterLoc Extension?
The FDA product code for MasterLoc Extension is LZO.
Other Devices by Medacta International S.A.
Related Devices (Code: LZO)
K160895Initia Total Hip System & BIOCERAM AZUL(R) HEADKyocera Medical Corporation
K161830Zimmer M/L Taper Hip ProsthesisZimmer, Inc.
K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH
K152893Corin Optimized Positioning System (OPS)Corin USA
K160289MasterLoc StemMedacta International
K152903REVIVAL(TM) Modular Revision Hip StemCorin USA
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.