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FDA 510(k)

Spine Innovation Interbody System

K-Number: K153356 · 2016-01-14

ApplicantSpine Innovation, LLC
Decision Date2016-01-14
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Spine Innovation Interbody System is a medical device manufactured by Spine Innovation, LLC. It received FDA 510(k) clearance on 2016-01-14 under approval number K153356. 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 Spine Innovation Interbody System?

Spine Innovation Interbody System is a medical device that received FDA 510(k) clearance on 2016-01-14. It is manufactured by Spine Innovation, LLC. The 510(k) number is K153356.

When was Spine Innovation Interbody System approved by the FDA?

Spine Innovation Interbody System received FDA 510(k) clearance on 2016-01-14, under approval number K153356.

What company makes Spine Innovation Interbody System?

Spine Innovation Interbody System is manufactured by Spine Innovation, LLC.

What is the FDA product code for Spine Innovation Interbody System?

The FDA product code for Spine Innovation 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 NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT07589023 A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis NOT_YET_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING

Related PubMed Literature

PMID: 41443207 Artificial Intelligence in UK Hospital Medicine: From Innovation to Implementation. British journal of hospital medicine (London, England : 2005) (2025) PMID: 40415770 Use of cardiovascular registries in regulatory pathways: perspectives from the EU-MDR Cardiovascular Collaboratory. REC, interventional cardiology (2024)

Other Devices by Spine Innovation, LLC

K253266Titanium 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.

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