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FDA 510(k)

ORTHO DEVELOPMENT BALANCED KNEE SYSTEM

K-Number: K994370 · 2000-03-24

ApplicantOrtho Development Corp.
Decision Date2000-03-24
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHO DEVELOPMENT BALANCED KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development Corp.. It received FDA 510(k) clearance on 2000-03-24 under 510(k) number K994370. 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 ORTHO DEVELOPMENT BALANCED KNEE SYSTEM?

ORTHO DEVELOPMENT BALANCED KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2000-03-24. The listed applicant is Ortho Development Corp.. The 510(k) number is K994370.

When did ORTHO DEVELOPMENT BALANCED KNEE SYSTEM receive FDA 510(k) clearance?

ORTHO DEVELOPMENT BALANCED KNEE SYSTEM received FDA 510(k) clearance on 2000-03-24, under 510(k) number K994370.

Who is the listed applicant for ORTHO DEVELOPMENT BALANCED KNEE SYSTEM?

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

What is the FDA product code for ORTHO DEVELOPMENT BALANCED KNEE SYSTEM?

The FDA product code for ORTHO DEVELOPMENT BALANCED KNEE 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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