HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1— 510(k) K031823

Substantially Equivalent

Implex Corp.

FDA 510(k) clearance K031823 for HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1, Substantially Equivalent on 2003-07-11. Applicant: Implex Corp..

Clearance details

Applicant: Implex Corp.
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2003-06-13
Decision date: 2003-07-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Allendale, NJ, US

Download summary PDF View on FDA.gov ↗

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.