FDA 510(k)

IMPLEX REPLACEMENT ACETABULAR CUP INSERT

K-Number: K964882 · 1997-03-13

Decision Date1997-03-13

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

IMPLEX REPLACEMENT ACETABULAR CUP INSERT is the device name listed in this FDA 510(k) record. The listed applicant is Implex Corp.. It received FDA 510(k) clearance on 1997-03-13 under 510(k) number K964882. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPLEX REPLACEMENT ACETABULAR CUP INSERT?

IMPLEX REPLACEMENT ACETABULAR CUP INSERT is a medical device that received FDA 510(k) clearance on 1997-03-13. The listed applicant is Implex Corp.. The 510(k) number is K964882.

When did IMPLEX REPLACEMENT ACETABULAR CUP INSERT receive FDA 510(k) clearance?

IMPLEX REPLACEMENT ACETABULAR CUP INSERT received FDA 510(k) clearance on 1997-03-13, under 510(k) number K964882.

Who is the listed applicant for IMPLEX REPLACEMENT ACETABULAR CUP INSERT?

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 REPLACEMENT ACETABULAR CUP INSERT?

The FDA product code for IMPLEX REPLACEMENT ACETABULAR CUP INSERT is LPH.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.