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FDA 510(k)

IMPLEX RADIAL HEAD REPLACEMENT SYSTEM

K-Number: K984290 · 1999-06-01

ApplicantImplex Corp.
Decision Date1999-06-01
Product CodeKWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IMPLEX RADIAL HEAD REPLACEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Implex Corp.. It received FDA 510(k) clearance on 1999-06-01 under 510(k) number K984290. The device is classified under product code KWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPLEX RADIAL HEAD REPLACEMENT SYSTEM?

IMPLEX RADIAL HEAD REPLACEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1999-06-01. The listed applicant is Implex Corp.. The 510(k) number is K984290.

When did IMPLEX RADIAL HEAD REPLACEMENT SYSTEM receive FDA 510(k) clearance?

IMPLEX RADIAL HEAD REPLACEMENT SYSTEM received FDA 510(k) clearance on 1999-06-01, under 510(k) number K984290.

Who is the listed applicant for IMPLEX RADIAL HEAD REPLACEMENT SYSTEM?

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 RADIAL HEAD REPLACEMENT SYSTEM?

The FDA product code for IMPLEX RADIAL HEAD REPLACEMENT SYSTEM is KWI.

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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: KWI)

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.

K260624Arthrex Radial Head Replacement SystemArthrex, Inc.K233592BioPoly Radial Head ImplantBioPoly, LLCK231188ALIGN Radial Head SystemSkeletal Dynamics, Inc.K213563DePuy Synthes Radial Head Replacement SystemDePuy SynthesK212872Avenger Radial Head SystemIn2bones USA, LLCK192754Avenger Radial Head SystemIn2bones USA, LLC

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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