TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1— 510(k) K051196

Substantially Equivalent

Implex Corp.

FDA 510(k) clearance K051196 for TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1, Substantially Equivalent on 2005-06-17. Applicant: Implex Corp..

Clearance details

Applicant: Implex Corp.
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2005-05-10
Decision date: 2005-06-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Allendale, NJ, US

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Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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.