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FDA 510(k)

3D Printed PEEK Interbody System

K-Number: K240250 · 2024-09-17

ApplicantNvision Biomedical Technologies, Inc.
Decision Date2024-09-17
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

3D Printed PEEK Interbody System is a medical device manufactured by Nvision Biomedical Technologies, Inc.. It received FDA 510(k) clearance on 2024-09-17 under approval number K240250. 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 3D Printed PEEK Interbody System?

3D Printed PEEK Interbody System is a medical device that received FDA 510(k) clearance on 2024-09-17. It is manufactured by Nvision Biomedical Technologies, Inc.. The 510(k) number is K240250.

When was 3D Printed PEEK Interbody System approved by the FDA?

3D Printed PEEK Interbody System received FDA 510(k) clearance on 2024-09-17, under approval number K240250.

What company makes 3D Printed PEEK Interbody System?

3D Printed PEEK Interbody System is manufactured by Nvision Biomedical Technologies, Inc..

What is the FDA product code for 3D Printed PEEK Interbody System?

The FDA product code for 3D Printed PEEK Interbody System is MAX.

Related Clinical Trials

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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

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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