S128 Anterior Lumbar Interbody Fusion (ALIF) System— 510(k) K180502

Substantially Equivalent

Renovis Surgical Technologies, Inc.

FDA 510(k) clearance K180502 for S128 Anterior Lumbar Interbody Fusion (ALIF) System, Substantially Equivalent on 2018-06-14. Applicant: Renovis Surgical Technologies, Inc..

Clearance details

Applicant: Renovis Surgical Technologies, Inc.
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2018-02-26
Decision date: 2018-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redlands, CA, US

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Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.