FDA 510(k)

Kodiak Lumbar Spacer System

K-Number: K230851 · 2023-05-26

Decision Date2023-05-26

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Kodiak Lumbar Spacer System is a medical device manufactured by Met One Technologies, LLC. It received FDA 510(k) clearance on 2023-05-26 under approval number K230851. 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 Kodiak Lumbar Spacer System?

Kodiak Lumbar Spacer System is a medical device that received FDA 510(k) clearance on 2023-05-26. It is manufactured by Met One Technologies, LLC. The 510(k) number is K230851.

When was Kodiak Lumbar Spacer System approved by the FDA?

Kodiak Lumbar Spacer System received FDA 510(k) clearance on 2023-05-26, under approval number K230851.

What company makes Kodiak Lumbar Spacer System?

Kodiak Lumbar Spacer System is manufactured by Met One Technologies, LLC.

What is the FDA product code for Kodiak Lumbar Spacer System?

The FDA product code for Kodiak Lumbar Spacer 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

Other Devices by Met One Technologies, LLC

K222806Kodiak C Spinal Implant System K250866Sovereign Posterior Cervical System K251732Wrist Fracture System

Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.

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.