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FDA 510(k)

ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System

K-Number: K260549 · 2026-04-24

ApplicantZsfab, Inc.
Decision Date2026-04-24
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System is a medical device manufactured by Zsfab, Inc.. It received FDA 510(k) clearance on 2026-04-24 under approval number K260549. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System?

ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2026-04-24. It is manufactured by Zsfab, Inc.. The 510(k) number is K260549.

When was ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System approved by the FDA?

ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System received FDA 510(k) clearance on 2026-04-24, under approval number K260549.

What company makes ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System?

ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System is manufactured by Zsfab, Inc..

What is the FDA product code for ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System?

The FDA product code for ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System is ODP.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07610850 Brain-controlled Spinal Cord Stimulation in Participants With Chronic Stroke for Lower and Upper Limb Rehabilitation NOT_YET_RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Zsfab, Inc.

K202488ZSFab Cervical Interbody System K221858ZSFab Lumbar Interbody System K232150ZSFab Cervical Interbody System K252610ZSFab Lumbar Interbody System

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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