FDA 510(k)

Quadra P

K-Number: K181254 · 2018-10-22

Decision Date2018-10-22

Product CodeLZO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Quadra P is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2018-10-22 under approval number K181254. 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 Quadra P?

Quadra P is a medical device that received FDA 510(k) clearance on 2018-10-22. It is manufactured by Medacta International S.A.. The 510(k) number is K181254.

When was Quadra P approved by the FDA?

Quadra P received FDA 510(k) clearance on 2018-10-22, under approval number K181254.

What company makes Quadra P?

Quadra P is manufactured by Medacta International S.A..

What is the FDA product code for Quadra P?

The FDA product code for Quadra P is LZO.

Other Devices by Medacta International S.A.

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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.