THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ— 510(k) K001471

Substantially Equivalent

Implex Corp.

FDA 510(k) clearance K001471 for THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ, Substantially Equivalent on 2000-08-07. Applicant: Implex Corp..

Clearance details

Applicant: Implex Corp.
Product code: Code LWJ
Advisory panel: Orthopedic
Date received: 2000-05-11
Decision date: 2000-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

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Adverse events under product code LWJ

product code LWJ

Injury: 544
Total: 544

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.