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FDA 510(k)

NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS

K-Number: K031962 · 2004-01-08

ApplicantImplex Corp.
Decision Date2004-01-08
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Implex Corp.. It received FDA 510(k) clearance on 2004-01-08 under 510(k) number K031962. 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 NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS?

NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS is a medical device that received FDA 510(k) clearance on 2004-01-08. The listed applicant is Implex Corp.. The 510(k) number is K031962.

When did NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS receive FDA 510(k) clearance?

NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS received FDA 510(k) clearance on 2004-01-08, under 510(k) number K031962.

Who is the listed applicant for NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS?

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 NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS?

The FDA product code for NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS 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-XXXXXK033384THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ

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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.

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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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