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FDA 510(k)

STYLO Interbody Fusion Device

K-Number: K180071 · 2018-05-03

ApplicantLegend Spine Technologies
Decision Date2018-05-03
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STYLO Interbody Fusion Device is a medical device manufactured by Legend Spine Technologies. It received FDA 510(k) clearance on 2018-05-03 under approval number K180071. 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 STYLO Interbody Fusion Device?

STYLO Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2018-05-03. It is manufactured by Legend Spine Technologies. The 510(k) number is K180071.

When was STYLO Interbody Fusion Device approved by the FDA?

STYLO Interbody Fusion Device received FDA 510(k) clearance on 2018-05-03, under approval number K180071.

What company makes STYLO Interbody Fusion Device?

STYLO Interbody Fusion Device is manufactured by Legend Spine Technologies.

What is the FDA product code for STYLO Interbody Fusion Device?

The FDA product code for STYLO Interbody Fusion Device is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07017634 Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease RECRUITING

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 38273730 Ten-Year Risk of Recall of Novel Spine Devices. Spine (2024)

Other Devices by Legend Spine Technologies

K192208CORNICE Cervical Spacer 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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