K033384

Substantially Equivalent

THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ

Applicant: Implex Corp.
Product code: JDK
Advisory panel: General, Plastic Surgery
Date received: 2003-10-23
Decision date: 2003-11-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Allendale, NJ, US

Download summary PDF View on FDA.gov ↗

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