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FDA 510(k)

ZSFab Lumbar Interbody System

K-Number: K221858 · 2022-10-14

ApplicantZsfab, Inc.
Decision Date2022-10-14
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZSFab Lumbar Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Zsfab, Inc.. It received FDA 510(k) clearance on 2022-10-14 under 510(k) number K221858. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZSFab Lumbar Interbody System?

ZSFab Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2022-10-14. The listed applicant is Zsfab, Inc.. The 510(k) number is K221858.

When did ZSFab Lumbar Interbody System receive FDA 510(k) clearance?

ZSFab Lumbar Interbody System received FDA 510(k) clearance on 2022-10-14, under 510(k) number K221858.

Who is the listed applicant for ZSFab Lumbar Interbody System?

The FDA 510(k) record lists Zsfab, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for ZSFab Lumbar Interbody System is MAX.

Other records listing Zsfab, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261451ZSAlign Cervical Interbody SystemK260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemK252610ZSFab Lumbar Interbody SystemK242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemK232150ZSFab Cervical Interbody SystemK202488ZSFab Cervical Interbody System

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Related Devices (Code: MAX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.

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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