CONSTRUX MINI PEEK TI SPACER SYSTEM— 510(k) K121649

Substantially Equivalent

Orthofix

FDA 510(k) clearance K121649 for CONSTRUX MINI PEEK TI SPACER SYSTEM, Substantially Equivalent on 2012-11-29. Applicant: Orthofix.

Clearance details

Applicant: Orthofix
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2012-06-05
Decision date: 2012-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lewisville, TX, US

Download summary PDF View on FDA.gov ↗

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.