Tailored-C Cervical Interbody Fusion System— 510(k) K200458

Substantially Equivalent

Bespoke Technologies

FDA 510(k) clearance K200458 for Tailored-C Cervical Interbody Fusion System, Substantially Equivalent on 2020-12-28. Applicant: Bespoke Technologies.

Clearance details

Applicant: Bespoke Technologies
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2020-02-25
Decision date: 2020-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winston-Salemn, NC, 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.