CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System— 510(k) K150619

Substantially Equivalent

Orthofix, Inc.

FDA 510(k) clearance K150619 for CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System, Substantially Equivalent on 2015-09-11. Applicant: Orthofix, Inc..

Clearance details

Applicant: Orthofix, Inc.
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2015-03-10
Decision date: 2015-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lewisville, 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.