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FDA 510(k)

THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ

K-Number: K001471 · 2000-08-07

ApplicantImplex Corp.
Decision Date2000-08-07
Product CodeLWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ is the device name listed in this FDA 510(k) record. The listed applicant is Implex Corp.. It received FDA 510(k) clearance on 2000-08-07 under 510(k) number K001471. The device is classified under product code LWJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ?

THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ is a medical device that received FDA 510(k) clearance on 2000-08-07. The listed applicant is Implex Corp.. The 510(k) number is K001471.

When did THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ receive FDA 510(k) clearance?

THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ received FDA 510(k) clearance on 2000-08-07, under 510(k) number K001471.

Who is the listed applicant for THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ?

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 THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ?

The FDA product code for THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ is LWJ.

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Other records listing Implex Corp. as applicant

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Related Devices (Code: LWJ)

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.

K120595UNISYN PLUS HIP STEMConsensus Orthopedics, Inc.K103518TRINITY ACETABULAR SYSTEMCorin USAK090764NOVATION CFS PRESS-FIT AND CEMENTED STEMSExactech, Inc.K082146METHA SHORT STEM HIP SYSTEM XL FEMORAL HEADAesculap Implant Systems, Inc.K07006136MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERTHayes Medical, Inc.K062978U2 HIP STEM, TI PLASMA SPRAYUnited Orthopedic Corp.

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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