THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND 02-293-28XX1 (IMPLEX PART #)— 510(k) K021970

Substantially Equivalent

Implex Corp.

FDA 510(k) clearance K021970 for THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND 02-293-28XX1 (IMPLEX PART #), Substantially Equivalent on 2002-07-12. Applicant: Implex Corp..

Clearance details

Applicant: Implex Corp.
Product code: Code LPH
Advisory panel: Orthopedic
Date received: 2002-06-17
Decision date: 2002-07-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Allendale, NJ, US

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Adverse events under product code LPH

product code LPH

Death: 73
Injury: 31,640
Malfunction: 3,358
Other: 2
Total: 35,073

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.