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FDA 510(k)

Pisces Spinal System

K-Number: K203023 · 2021-07-14

ApplicantOrtho Development Corporation
Decision Date2021-07-14
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Pisces Spinal System is a medical device manufactured by Ortho Development Corporation. It received FDA 510(k) clearance on 2021-07-14 under approval number K203023. 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 Pisces Spinal System?

Pisces Spinal System is a medical device that received FDA 510(k) clearance on 2021-07-14. It is manufactured by Ortho Development Corporation. The 510(k) number is K203023.

When was Pisces Spinal System approved by the FDA?

Pisces Spinal System received FDA 510(k) clearance on 2021-07-14, under approval number K203023.

What company makes Pisces Spinal System?

Pisces Spinal System is manufactured by Ortho Development Corporation.

What is the FDA product code for Pisces Spinal System?

The FDA product code for Pisces Spinal System is NKB.

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Related PubMed Literature

PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022)

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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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