ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System— 510(k) K242734

Substantially Equivalent

Zsfab

FDA 510(k) clearance K242734 for ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System, Substantially Equivalent on 2024-11-07. Applicant: Zsfab.

Clearance details

Applicant: Zsfab
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2024-09-10
Decision date: 2024-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, 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.