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FDA 510(k)

GEM KNEE SYSTEM

K-Number: K994214 · 2000-07-19

ApplicantKinamed, Inc.
Decision Date2000-07-19
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GEM KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kinamed, Inc.. It received FDA 510(k) clearance on 2000-07-19 under 510(k) number K994214. 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 GEM KNEE SYSTEM?

GEM KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2000-07-19. The listed applicant is Kinamed, Inc.. The 510(k) number is K994214.

When did GEM KNEE SYSTEM receive FDA 510(k) clearance?

GEM KNEE SYSTEM received FDA 510(k) clearance on 2000-07-19, under 510(k) number K994214.

Who is the listed applicant for GEM KNEE SYSTEM?

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

What is the FDA product code for GEM KNEE SYSTEM?

The FDA product code for GEM KNEE SYSTEM is JWH.

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Other records listing Kinamed, Inc. 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.

K122049NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEMK072250SUPERCABLE GRIP AND PLATE SYSTEMK050897NAVIPRO SHOULDER SOFTWARE MODULEK033668NAVIPRO KNEE SOFTWARE MODULEK032950GEM INSET PATELLAR COMPONENTK030256ISO-ELASTIC CERCLAGE SYSTEM

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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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