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FDA 510(k)

Oculus-SA Lumbar Cage System

K-Number: K202190 · 2020-10-02

ApplicantNeurostructures
Decision Date2020-10-02
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Oculus-SA Lumbar Cage System is a medical device manufactured by Neurostructures. It received FDA 510(k) clearance on 2020-10-02 under approval number K202190. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Oculus-SA Lumbar Cage System?

Oculus-SA Lumbar Cage System is a medical device that received FDA 510(k) clearance on 2020-10-02. It is manufactured by Neurostructures. The 510(k) number is K202190.

When was Oculus-SA Lumbar Cage System approved by the FDA?

Oculus-SA Lumbar Cage System received FDA 510(k) clearance on 2020-10-02, under approval number K202190.

What company makes Oculus-SA Lumbar Cage System?

Oculus-SA Lumbar Cage System is manufactured by Neurostructures.

What is the FDA product code for Oculus-SA Lumbar Cage System?

The FDA product code for Oculus-SA Lumbar Cage System is OVD.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT07277803 Device-Based vs Manual Sensory Training in Low Back Pain NOT_YET_RECRUITING NCT06011551 HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs RECRUITING NCT07494812 Examining the Feasibility of Using Pressure Gradient Regulated Automated Cerebral Spinal Fluid Drainage During External Lumbar Drain Trials NOT_YET_RECRUITING NCT07214844 A Prospective Study to Evaluate the Efficacy of Iovera Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain RECRUITING

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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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