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FDA 510(k)

BALANCED KNEE SYSTEM REVISION OFFSET TIBIA

K-Number: K103837 · 2011-03-24

ApplicantOrtho Development
Decision Date2011-03-24
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BALANCED KNEE SYSTEM REVISION OFFSET TIBIA is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development. It received FDA 510(k) clearance on 2011-03-24 under 510(k) number K103837. 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 BALANCED KNEE SYSTEM REVISION OFFSET TIBIA?

BALANCED KNEE SYSTEM REVISION OFFSET TIBIA is a medical device that received FDA 510(k) clearance on 2011-03-24. The listed applicant is Ortho Development. The 510(k) number is K103837.

When did BALANCED KNEE SYSTEM REVISION OFFSET TIBIA receive FDA 510(k) clearance?

BALANCED KNEE SYSTEM REVISION OFFSET TIBIA received FDA 510(k) clearance on 2011-03-24, under 510(k) number K103837.

Who is the listed applicant for BALANCED KNEE SYSTEM REVISION OFFSET TIBIA?

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

What is the FDA product code for BALANCED KNEE SYSTEM REVISION OFFSET TIBIA?

The FDA product code for BALANCED KNEE SYSTEM REVISION OFFSET TIBIA is JWH.

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Other records listing Ortho Development 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.

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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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