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FDA 510(k)

Uni-C Cervical Cage System

K-Number: K252774 · 2026-04-15

ApplicantZheJiang Decans Medical Devices Co., Ltd.
Decision Date2026-04-15
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Uni-C Cervical Cage System is a medical device manufactured by ZheJiang Decans Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2026-04-15 under approval number K252774. 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 Uni-C Cervical Cage System?

Uni-C Cervical Cage System is a medical device that received FDA 510(k) clearance on 2026-04-15. It is manufactured by ZheJiang Decans Medical Devices Co., Ltd.. The 510(k) number is K252774.

When was Uni-C Cervical Cage System approved by the FDA?

Uni-C Cervical Cage System received FDA 510(k) clearance on 2026-04-15, under approval number K252774.

What company makes Uni-C Cervical Cage System?

Uni-C Cervical Cage System is manufactured by ZheJiang Decans Medical Devices Co., Ltd..

What is the FDA product code for Uni-C Cervical Cage System?

The FDA product code for Uni-C 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 K253213SAGI Cervical Cage System

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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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