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FDA 510(k)

ORION Spinal System

K-Number: K190600 · 2020-08-18

ApplicantOrion Biotech, Inc.
Decision Date2020-08-18
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORION Spinal System is a medical device manufactured by Orion Biotech, Inc.. It received FDA 510(k) clearance on 2020-08-18 under approval number K190600. 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 ORION Spinal System?

ORION Spinal System is a medical device that received FDA 510(k) clearance on 2020-08-18. It is manufactured by Orion Biotech, Inc.. The 510(k) number is K190600.

When was ORION Spinal System approved by the FDA?

ORION Spinal System received FDA 510(k) clearance on 2020-08-18, under approval number K190600.

What company makes ORION Spinal System?

ORION Spinal System is manufactured by Orion Biotech, Inc..

What is the FDA product code for ORION Spinal System?

The FDA product code for ORION 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)

Related Devices (Code: NKB)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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