FDA 510(k)

Titanium Interbody System

K-Number: K253266 · 2026-01-08

Decision Date2026-01-08

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Titanium Interbody System is a medical device manufactured by Spine Innovation, LLC. It received FDA 510(k) clearance on 2026-01-08 under approval number K253266. 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 Titanium Interbody System?

Titanium Interbody System is a medical device that received FDA 510(k) clearance on 2026-01-08. It is manufactured by Spine Innovation, LLC. The 510(k) number is K253266.

When was Titanium Interbody System approved by the FDA?

Titanium Interbody System received FDA 510(k) clearance on 2026-01-08, under approval number K253266.

What company makes Titanium Interbody System?

Titanium Interbody System is manufactured by Spine Innovation, LLC.

What is the FDA product code for Titanium Interbody System?

The FDA product code for Titanium Interbody System is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07569575 Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures NOT_YET_RECRUITING NCT07538141 The Hyalex MTP Study RECRUITING

Related PubMed Literature

PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Spine Innovation, LLC

K153356Spine Innovation Interbody 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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.