Summit Spine Channel Cervical Interbody Fusion System— 510(k) K163494

Substantially Equivalent

Summit Spine

FDA 510(k) clearance K163494 for Summit Spine Channel Cervical Interbody Fusion System, Substantially Equivalent on 2017-06-20. Applicant: Summit Spine.

Clearance details

Applicant: Summit Spine
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2016-12-13
Decision date: 2017-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Georgetown, 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.