LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS— 510(k) K113559

Substantially Equivalent

Ldr Spine USA, Inc.

FDA 510(k) clearance K113559 for LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS, Substantially Equivalent on 2011-12-29. Applicant: Ldr Spine USA, Inc..

Clearance details

Applicant: Ldr Spine USA, Inc.
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2011-12-01
Decision date: 2011-12-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, 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.