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FDA 510(k)

PROFEMUR TL2 Stems

K-Number: K191632 · 2019-10-07

ApplicantMicroport Orthopedics, Inc.
Decision Date2019-10-07
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROFEMUR TL2 Stems is a medical device manufactured by Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2019-10-07 under approval number K191632. 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 PROFEMUR TL2 Stems?

PROFEMUR TL2 Stems is a medical device that received FDA 510(k) clearance on 2019-10-07. It is manufactured by Microport Orthopedics, Inc.. The 510(k) number is K191632.

When was PROFEMUR TL2 Stems approved by the FDA?

PROFEMUR TL2 Stems received FDA 510(k) clearance on 2019-10-07, under approval number K191632.

What company makes PROFEMUR TL2 Stems?

PROFEMUR TL2 Stems is manufactured by Microport Orthopedics, Inc..

What is the FDA product code for PROFEMUR TL2 Stems?

The FDA product code for PROFEMUR TL2 Stems is LZO.

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: LZO)

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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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