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FDA 510(k)

REVIVAL(TM) Modular Revision Hip Stem

K-Number: K152903 · 2016-04-29

ApplicantCorin USA
Decision Date2016-04-29
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REVIVAL(TM) Modular Revision Hip Stem is a medical device manufactured by Corin USA. It received FDA 510(k) clearance on 2016-04-29 under approval number K152903. 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 REVIVAL(TM) Modular Revision Hip Stem?

REVIVAL(TM) Modular Revision Hip Stem is a medical device that received FDA 510(k) clearance on 2016-04-29. It is manufactured by Corin USA. The 510(k) number is K152903.

When was REVIVAL(TM) Modular Revision Hip Stem approved by the FDA?

REVIVAL(TM) Modular Revision Hip Stem received FDA 510(k) clearance on 2016-04-29, under approval number K152903.

What company makes REVIVAL(TM) Modular Revision Hip Stem?

REVIVAL(TM) Modular Revision Hip Stem is manufactured by Corin USA.

What is the FDA product code for REVIVAL(TM) Modular Revision Hip Stem?

The FDA product code for REVIVAL(TM) Modular Revision Hip Stem is LZO.

Other Devices by Corin USA

K152893Corin Optimized Positioning System (OPS) K183038Corin Optimized Positioning System (OPS) Plan K181061Corin Optimized Positioning System (OPS) Femoral K190143LARS AC Band Device K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA) K202805Optimized Positioning System (OPS) Insight

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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 K152530UCP StemUnited Orthopedic Corporation

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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