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FDA 510(k)

SAGI Cervical Cage System

K-Number: K253213 · 2026-04-20

ApplicantZheJiang Decans Medical Devices Co., Ltd.
Decision Date2026-04-20
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SAGI Cervical Cage System is the device name listed in this FDA 510(k) record. The listed applicant is ZheJiang Decans Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2026-04-20 under 510(k) number K253213. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAGI Cervical Cage System?

SAGI Cervical Cage System is a medical device that received FDA 510(k) clearance on 2026-04-20. The listed applicant is ZheJiang Decans Medical Devices Co., Ltd.. The 510(k) number is K253213.

When did SAGI Cervical Cage System receive FDA 510(k) clearance?

SAGI Cervical Cage System received FDA 510(k) clearance on 2026-04-20, under 510(k) number K253213.

Who is the listed applicant for SAGI Cervical Cage System?

The FDA 510(k) record lists ZheJiang Decans Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAGI Cervical Cage System?

The FDA product code for SAGI Cervical Cage System is OVE.

Other records listing ZheJiang Decans Medical Devices Co., Ltd. as applicant

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K253046HERA Interlocking Intramedullary Nailing SystemK253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsK253130Dione PEEK Screw SystemK252930AQUA Laminoplasty SystemsK252776ARIES Anterior Cervical Plate SystemsK252542LEO Spinal System

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Related Devices (Code: OVE)

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 SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

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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