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FDA 510(k)

CORUS Spinal System-X

K-Number: K212636 · 2021-10-15

ApplicantProvidence Medical Technology, Inc.
Decision Date2021-10-15
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CORUS Spinal System-X is a medical device manufactured by Providence Medical Technology, Inc.. It received FDA 510(k) clearance on 2021-10-15 under approval number K212636. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORUS Spinal System-X?

CORUS Spinal System-X is a medical device that received FDA 510(k) clearance on 2021-10-15. It is manufactured by Providence Medical Technology, Inc.. The 510(k) number is K212636.

When was CORUS Spinal System-X approved by the FDA?

CORUS Spinal System-X received FDA 510(k) clearance on 2021-10-15, under approval number K212636.

What company makes CORUS Spinal System-X?

CORUS Spinal System-X is manufactured by Providence Medical Technology, Inc..

What is the FDA product code for CORUS Spinal System-X?

The FDA product code for CORUS Spinal System-X is HRX.

Related Clinical Trials

NCT06998134 Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06087445 A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia COMPLETED

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)

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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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