FUSION ADVANTAGE CERVICAL CAGE, FUSION ADVANTAGE LUMBAR CAGE— 510(k) K083425

Substantially Equivalent

Adaptive Specialty, LLC

FDA 510(k) clearance K083425 for FUSION ADVANTAGE CERVICAL CAGE, FUSION ADVANTAGE LUMBAR CAGE, Substantially Equivalent on 2009-03-20. Applicant: Adaptive Specialty, LLC.

Clearance details

Applicant: Adaptive Specialty, LLC
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2008-11-19
Decision date: 2009-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Rock, TX, US

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Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.