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FDA 510(k)

ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM

K-Number: K093567 · 2010-02-05

ApplicantAnova Implant Solutions, LLC
Decision Date2010-02-05
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Anova Implant Solutions, LLC. It received FDA 510(k) clearance on 2010-02-05 under 510(k) number K093567. 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 ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM?

ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2010-02-05. The listed applicant is Anova Implant Solutions, LLC. The 510(k) number is K093567.

When did ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM receive FDA 510(k) clearance?

ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM received FDA 510(k) clearance on 2010-02-05, under 510(k) number K093567.

Who is the listed applicant for ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM?

The FDA 510(k) record lists Anova Implant Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM?

The FDA product code for ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM is JWH.

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Related Devices (Code: JWH)

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.

K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

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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