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FDA 510(k)

EVOLUTION Stemmed CS Femur

K-Number: K182125 · 2018-12-06

ApplicantMicroport Orthopedics, Inc.
Decision Date2018-12-06
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EVOLUTION Stemmed CS Femur is a medical device manufactured by Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2018-12-06 under approval number K182125. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVOLUTION Stemmed CS Femur?

EVOLUTION Stemmed CS Femur is a medical device that received FDA 510(k) clearance on 2018-12-06. It is manufactured by Microport Orthopedics, Inc.. The 510(k) number is K182125.

When was EVOLUTION Stemmed CS Femur approved by the FDA?

EVOLUTION Stemmed CS Femur received FDA 510(k) clearance on 2018-12-06, under approval number K182125.

What company makes EVOLUTION Stemmed CS Femur?

EVOLUTION Stemmed CS Femur is manufactured by Microport Orthopedics, Inc..

What is the FDA product code for EVOLUTION Stemmed CS Femur?

The FDA product code for EVOLUTION Stemmed CS Femur is JWH.

Other Devices by Microport Orthopedics, Inc.

K152631MPO Total Knee Systems MR Labeling K171181PROCOTYL® PRIME E-CLASS™ XLPE Liner K171389EVOLUTION Revision CCK System K170444PROCOTYL® PRIME Acetabular Cup System K170288BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell K162026EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions

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Related Devices (Code: JWH)

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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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