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FDA 510(k)

SAGICO OSI Spinal System by Osimplant

K-Number: K180220 · 2018-05-21

ApplicantSpinal Analytics & Geometrical Implant Co, LLC
Decision Date2018-05-21
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SAGICO OSI Spinal System by Osimplant is a medical device manufactured by Spinal Analytics & Geometrical Implant Co, LLC. It received FDA 510(k) clearance on 2018-05-21 under approval number K180220. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAGICO OSI Spinal System by Osimplant?

SAGICO OSI Spinal System by Osimplant is a medical device that received FDA 510(k) clearance on 2018-05-21. It is manufactured by Spinal Analytics & Geometrical Implant Co, LLC. The 510(k) number is K180220.

When was SAGICO OSI Spinal System by Osimplant approved by the FDA?

SAGICO OSI Spinal System by Osimplant received FDA 510(k) clearance on 2018-05-21, under approval number K180220.

What company makes SAGICO OSI Spinal System by Osimplant?

SAGICO OSI Spinal System by Osimplant is manufactured by Spinal Analytics & Geometrical Implant Co, LLC.

What is the FDA product code for SAGICO OSI Spinal System by Osimplant?

The FDA product code for SAGICO OSI Spinal System by Osimplant is NKB.

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 Spinal Analytics & Geometrical Implant Co, LLC

K233191TotalTi ACDF by SAGICO

Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, 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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