FDA 510(k)

Summit Hip System

K-Number: K170339 · 2018-04-26

Decision Date2018-04-26

Product CodeLZO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Summit Hip System is a medical device manufactured by DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2018-04-26 under approval number K170339. 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 Summit Hip System?

Summit Hip System is a medical device that received FDA 510(k) clearance on 2018-04-26. It is manufactured by DePuy Orthopaedics, Inc.. The 510(k) number is K170339.

When was Summit Hip System approved by the FDA?

Summit Hip System received FDA 510(k) clearance on 2018-04-26, under approval number K170339.

What company makes Summit Hip System?

Summit Hip System is manufactured by DePuy Orthopaedics, Inc..

What is the FDA product code for Summit Hip System?

The FDA product code for Summit Hip System is LZO.

Other Devices by DePuy Orthopaedics, Inc.

K192919Pinnacle Duofix HA Acetabular Cup Prosthesis K192946DePuy Corail AMT Hip Prosthesis K182301PFC SIGMA Knee System K203167DePuy Corail AMT Hip Prosthesis K202472ACTIS Duofix Hip Prosthesis K201347DePuy ATTUNE Total Knee System

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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.