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FDA 510(k)

SLED UNICOMPARTMENT KNEE SYSTEM

K-Number: K954186 · 1996-01-26

ApplicantLink America, Inc.
Decision Date1996-01-26
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SLED UNICOMPARTMENT KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Link America, Inc.. It received FDA 510(k) clearance on 1996-01-26 under 510(k) number K954186. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLED UNICOMPARTMENT KNEE SYSTEM?

SLED UNICOMPARTMENT KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 1996-01-26. The listed applicant is Link America, Inc.. The 510(k) number is K954186.

When did SLED UNICOMPARTMENT KNEE SYSTEM receive FDA 510(k) clearance?

SLED UNICOMPARTMENT KNEE SYSTEM received FDA 510(k) clearance on 1996-01-26, under 510(k) number K954186.

Who is the listed applicant for SLED UNICOMPARTMENT KNEE SYSTEM?

The FDA 510(k) record lists Link America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SLED UNICOMPARTMENT KNEE SYSTEM?

The FDA product code for SLED UNICOMPARTMENT KNEE SYSTEM is HSX.

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Other records listing Link America, Inc. as applicant

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Related Devices (Code: HSX)

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K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc.K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus OrthopedicsK251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.K251834Persona Partial KneeZimmer BiometK251618MOTO Partial Knee System ExtensionMedacta International S.A.K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.

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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