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FDA 510(k)

ZSFab Cervical Interbody System

K-Number: K202488 · 2021-01-07

ApplicantZsfab, Inc.
Decision Date2021-01-07
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZSFab Cervical 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 2021-01-07 under 510(k) number K202488. 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?

ZSFab Cervical Interbody System is a medical device that received FDA 510(k) clearance on 2021-01-07. The listed applicant is Zsfab, Inc.. The 510(k) number is K202488.

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

ZSFab Cervical Interbody System received FDA 510(k) clearance on 2021-01-07, under 510(k) number K202488.

Who is the listed applicant for ZSFab Cervical 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 Cervical Interbody System?

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

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 SystemK221858ZSFab Lumbar Interbody System

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Related Devices (Code: ODP)

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.

K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, 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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