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FDA 510(k)

REVELATION STEM, MODEL 427-21/42-080/180

K-Number: K083651 · 2009-03-13

ApplicantEncore Medical L.P.
Decision Date2009-03-13
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REVELATION STEM, MODEL 427-21/42-080/180 is the device name listed in this FDA 510(k) record. The listed applicant is Encore Medical L.P.. It received FDA 510(k) clearance on 2009-03-13 under 510(k) number K083651. The device is classified under product code KWA. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REVELATION STEM, MODEL 427-21/42-080/180?

REVELATION STEM, MODEL 427-21/42-080/180 is a medical device that received FDA 510(k) clearance on 2009-03-13. The listed applicant is Encore Medical L.P.. The 510(k) number is K083651.

When did REVELATION STEM, MODEL 427-21/42-080/180 receive FDA 510(k) clearance?

REVELATION STEM, MODEL 427-21/42-080/180 received FDA 510(k) clearance on 2009-03-13, under 510(k) number K083651.

Who is the listed applicant for REVELATION STEM, MODEL 427-21/42-080/180?

The FDA 510(k) record lists Encore Medical L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REVELATION STEM, MODEL 427-21/42-080/180?

The FDA product code for REVELATION STEM, MODEL 427-21/42-080/180 is KWA.

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Related Devices (Code: KWA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K122778PROFEMUR Z REVISION HIP STEMWrightmedicaltechnologyincK121544DYNASTY BIOFOAM SHELLWrightmedicaltechnologyincK113271METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONSBiomet Manufacturing, Inc.K113322CONSERVE THIN SHELLWrightmedicaltechnologyincK112080PRESERVE HIP STEMWrightmedicaltechnologyincK112150PROFEMUR GLADIATOR HA HIP STEMWrightmedicaltechnologyinc

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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