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FDA 510(k)

FREEDOM METAL BACKED TIBIAL COMPONENT

K-Number: K090411 · 2009-04-07

ApplicantMaxx Orthopedics, Inc.
Decision Date2009-04-07
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FREEDOM METAL BACKED TIBIAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Maxx Orthopedics, Inc.. It received FDA 510(k) clearance on 2009-04-07 under 510(k) number K090411. 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 FREEDOM METAL BACKED TIBIAL COMPONENT?

FREEDOM METAL BACKED TIBIAL COMPONENT is a medical device that received FDA 510(k) clearance on 2009-04-07. The listed applicant is Maxx Orthopedics, Inc.. The 510(k) number is K090411.

When did FREEDOM METAL BACKED TIBIAL COMPONENT receive FDA 510(k) clearance?

FREEDOM METAL BACKED TIBIAL COMPONENT received FDA 510(k) clearance on 2009-04-07, under 510(k) number K090411.

Who is the listed applicant for FREEDOM METAL BACKED TIBIAL COMPONENT?

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

What is the FDA product code for FREEDOM METAL BACKED TIBIAL COMPONENT?

The FDA product code for FREEDOM METAL BACKED TIBIAL COMPONENT is JWH.

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Other records listing Maxx Orthopedics, Inc. as applicant

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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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