ZSFab Cervical Interbody System— 510(k) K202488

Substantially Equivalent

Zsfab, Inc.

FDA 510(k) clearance K202488 for ZSFab Cervical Interbody System, Substantially Equivalent on 2021-01-07. Applicant: Zsfab, Inc..

Clearance details

Applicant: Zsfab, Inc.
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2020-08-31
Decision date: 2021-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, 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.