LDR SPINE CERVICAL INTERBODY FUSION SYSTEM— 510(k) K091088

Substantially Equivalent

Ldr Spine USA

FDA 510(k) clearance K091088 for LDR SPINE CERVICAL INTERBODY FUSION SYSTEM, Substantially Equivalent on 2009-07-14. Applicant: Ldr Spine USA.

Clearance details

Applicant: Ldr Spine USA
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2009-04-15
Decision date: 2009-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, 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.