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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 a medical device manufactured by ZheJiang Decans Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2026-04-20 under approval 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. It is manufactured by ZheJiang Decans Medical Devices Co., Ltd.. The 510(k) number is K253213.

When was SAGI Cervical Cage System approved by the FDA?

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

What company makes SAGI Cervical Cage System?

SAGI Cervical Cage System is manufactured by ZheJiang Decans Medical Devices Co., Ltd..

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

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

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Other Devices by ZheJiang Decans Medical Devices Co., Ltd.

K242195Gemini Cervical Fusion Cage System K242267Gemini Medical Cage System K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor) K252776ARIES Anterior Cervical Plate Systems K252542LEO Spinal System K252774Uni-C Cervical Cage System

View all 7 devices →

Related Devices (Code: OVE)

K162531STERISPINE CCSafe Orthopaedics K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, 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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