ZSFab

Timeline

1. Jul 31, 2026 FDA FDA 510(k) clearance: ZSAlign Cervical Interbody System — K261451, Jul 31, 2026. Applicant at approval: ZSFab, Inc. source ↗
2. Apr 24, 2026 FDA FDA 510(k) clearance: ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System — K260549, Apr 24, 2026. Applicant at approval: Zsfab, Inc. source ↗
3. Nov 25, 2025 FDA FDA 510(k) clearance: ZSFab Lumbar Interbody System — K252610, Nov 25, 2025. Applicant at approval: Zsfab, Inc. source ↗
4. Nov 7, 2024 FDA FDA 510(k) clearance: ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System — K242734, Nov 7, 2024. Applicant at approval: Zsfab. source ↗

FDA records (last 2 years)

• Jul 31, 2026 FDA 510(k) clearance: ZSAlign Cervical Interbody System — K261451, Jul 31, 2026. Applicant at approval: ZSFab, Inc. source ↗
• Apr 24, 2026 FDA 510(k) clearance: ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System — K260549, Apr 24, 2026. Applicant at approval: Zsfab, Inc. source ↗
• Nov 25, 2025 FDA 510(k) clearance: ZSFab Lumbar Interbody System — K252610, Nov 25, 2025. Applicant at approval: Zsfab, Inc. source ↗
• Nov 7, 2024 FDA 510(k) clearance: ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System — K242734, Nov 7, 2024. Applicant at approval: Zsfab. source ↗