HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015— 510(k) K081758

Substantially Equivalent

Depuy Spine, Inc.

FDA 510(k) clearance K081758 for HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015, Substantially Equivalent on 2008-09-03. Applicant: Depuy Spine, Inc..

Clearance details

Applicant: Depuy Spine, Inc.
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2008-06-20
Decision date: 2008-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

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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.