OSSIPRO BONE SUBSTITUTE MATERIAL— 510(k) K062630

Substantially Equivalent

Etex Corp.

FDA 510(k) clearance K062630 for OSSIPRO BONE SUBSTITUTE MATERIAL, Substantially Equivalent on 2007-06-28. Applicant: Etex Corp..

Clearance details

Applicant: Etex Corp.
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2006-09-05
Decision date: 2007-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQV

product code MQV

Death: 6
Injury: 435
Total: 441

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.