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FDA 510(k)

Ripley Spinal Screw System by SAGICO

K-Number: K232561 · 2023-10-23

ApplicantSagico VA USA, LLC
Decision Date2023-10-23
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Ripley Spinal Screw System by SAGICO is a medical device manufactured by Sagico VA USA, LLC. It received FDA 510(k) clearance on 2023-10-23 under approval number K232561. 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 Ripley Spinal Screw System by SAGICO?

Ripley Spinal Screw System by SAGICO is a medical device that received FDA 510(k) clearance on 2023-10-23. It is manufactured by Sagico VA USA, LLC. The 510(k) number is K232561.

When was Ripley Spinal Screw System by SAGICO approved by the FDA?

Ripley Spinal Screw System by SAGICO received FDA 510(k) clearance on 2023-10-23, under approval number K232561.

What company makes Ripley Spinal Screw System by SAGICO?

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

What is the FDA product code for Ripley Spinal Screw System by SAGICO?

The FDA product code for Ripley Spinal Screw System by SAGICO 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 Sagico VA USA, LLC

K221138Titus Titanium Cervical by SAGICO K223143SAGICO Spinal System

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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