INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD)— 510(k) K081194

Substantially Equivalent

Rsb Spine, LLC

FDA 510(k) clearance K081194 for INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD), Substantially Equivalent on 2008-05-29. Applicant: Rsb Spine, LLC.

Clearance details

Applicant: Rsb Spine, LLC
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2008-04-28
Decision date: 2008-05-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Chesterland, OH, US

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Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

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.