HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM— 510(k) K062495

Substantially Equivalent

Depuy Spine, Inc.

FDA 510(k) clearance K062495 for HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM, Substantially Equivalent on 2006-10-13. Applicant: Depuy Spine, Inc..

Clearance details

Applicant: Depuy Spine, Inc.
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2006-08-25
Decision date: 2006-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, 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.