FDA 510(k)

CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ

K-Number: K990330 · 2000-03-01

Decision Date2000-03-01

Product CodeJDI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ is the device name listed in this FDA 510(k) record. The listed applicant is Implex Corp.. It received FDA 510(k) clearance on 2000-03-01 under 510(k) number K990330. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ?

CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ is a medical device that received FDA 510(k) clearance on 2000-03-01. The listed applicant is Implex Corp.. The 510(k) number is K990330.

When did CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ receive FDA 510(k) clearance?

CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ received FDA 510(k) clearance on 2000-03-01, under 510(k) number K990330.

Who is the listed applicant for CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ?

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 CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ?

The FDA product code for CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ is JDI.

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Other records listing Implex Corp. as applicant

K051978TRABECULAR METAL VERTEBRAL BODY REPLACEMENT K051196TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1 K040487TRABECULAR METAL KNEE SYSTEM AUGMENTS K040630TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ K040756THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX K031962NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS

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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.