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FDA 510(k)

IMPLEX CONTINUUM KNEE UNITY TIBIAL COMPONENT

K-Number: K980637 · 1998-12-16

ApplicantImplex Corp.
Decision Date1998-12-16
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IMPLEX CONTINUUM KNEE UNITY TIBIAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Implex Corp.. It received FDA 510(k) clearance on 1998-12-16 under 510(k) number K980637. 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 IMPLEX CONTINUUM KNEE UNITY TIBIAL COMPONENT?

IMPLEX CONTINUUM KNEE UNITY TIBIAL COMPONENT is a medical device that received FDA 510(k) clearance on 1998-12-16. The listed applicant is Implex Corp.. The 510(k) number is K980637.

When did IMPLEX CONTINUUM KNEE UNITY TIBIAL COMPONENT receive FDA 510(k) clearance?

IMPLEX CONTINUUM KNEE UNITY TIBIAL COMPONENT received FDA 510(k) clearance on 1998-12-16, under 510(k) number K980637.

Who is the listed applicant for IMPLEX CONTINUUM KNEE UNITY TIBIAL COMPONENT?

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

What is the FDA product code for IMPLEX CONTINUUM KNEE UNITY TIBIAL COMPONENT?

The FDA product code for IMPLEX CONTINUUM KNEE UNITY TIBIAL COMPONENT is JWH.

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Other records listing Implex Corp. 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.

K051978TRABECULAR METAL VERTEBRAL BODY REPLACEMENTK051196TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1K040487TRABECULAR METAL KNEE SYSTEM AUGMENTSK040630TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZK040756THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXXK031962NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS

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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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