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FDA 510(k)

ACCIN UNI-KNEE SYSTEM

K-Number: K063782 · 2007-01-19

ApplicantAccin Corporation
Decision Date2007-01-19
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACCIN UNI-KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Accin Corporation. It received FDA 510(k) clearance on 2007-01-19 under 510(k) number K063782. 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 ACCIN UNI-KNEE SYSTEM?

ACCIN UNI-KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2007-01-19. The listed applicant is Accin Corporation. The 510(k) number is K063782.

When did ACCIN UNI-KNEE SYSTEM receive FDA 510(k) clearance?

ACCIN UNI-KNEE SYSTEM received FDA 510(k) clearance on 2007-01-19, under 510(k) number K063782.

Who is the listed applicant for ACCIN UNI-KNEE SYSTEM?

The FDA 510(k) record lists Accin Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCIN UNI-KNEE SYSTEM?

The FDA product code for ACCIN UNI-KNEE SYSTEM is HSX.

Related Clinical Trials

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.

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Other records listing Accin Corporation as applicant

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.

K060670ACCIN UNI-KNEE SYSTEM

Related Devices (Code: HSX)

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.

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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