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FDA 510(k)

SAGICO Spinal System

K-Number: K223143 · 2023-06-26

ApplicantSagico VA USA, LLC
Decision Date2023-06-26
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SAGICO Spinal System is a medical device manufactured by Sagico VA USA, LLC. It received FDA 510(k) clearance on 2023-06-26 under approval number K223143. 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 SAGICO Spinal System?

SAGICO Spinal System is a medical device that received FDA 510(k) clearance on 2023-06-26. It is manufactured by Sagico VA USA, LLC. The 510(k) number is K223143.

When was SAGICO Spinal System approved by the FDA?

SAGICO Spinal System received FDA 510(k) clearance on 2023-06-26, under approval number K223143.

What company makes SAGICO Spinal System?

SAGICO Spinal System is manufactured by Sagico VA USA, LLC.

What is the FDA product code for SAGICO Spinal System?

The FDA product code for SAGICO Spinal System is OVE.

Related Clinical Trials

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Sagico VA USA, LLC

K232561Ripley Spinal Screw System by SAGICO K221138Titus Titanium Cervical by SAGICO

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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