FDA 510(k)

SWINGO-3D Lumbar Cage System

K-Number: K254017 · 2026-02-26

Decision Date2026-02-26

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SWINGO-3D Lumbar Cage System is a medical device manufactured by Implanet. It received FDA 510(k) clearance on 2026-02-26 under approval number K254017. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SWINGO-3D Lumbar Cage System?

SWINGO-3D Lumbar Cage System is a medical device that received FDA 510(k) clearance on 2026-02-26. It is manufactured by Implanet. The 510(k) number is K254017.

When was SWINGO-3D Lumbar Cage System approved by the FDA?

SWINGO-3D Lumbar Cage System received FDA 510(k) clearance on 2026-02-26, under approval number K254017.

What company makes SWINGO-3D Lumbar Cage System?

SWINGO-3D Lumbar Cage System is manufactured by Implanet.

What is the FDA product code for SWINGO-3D Lumbar Cage System?

The FDA product code for SWINGO-3D Lumbar Cage System is MAX.

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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Related Devices (Code: MAX)

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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.