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FDA 510(k)

Endoskeleton TO Interbody Fusion Device (IBD)

K-Number: K170399 · 2017-07-06

ApplicantTitan Spine, LLC
Decision Date2017-07-06
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Endoskeleton TO Interbody Fusion Device (IBD) is a medical device manufactured by Titan Spine, LLC. It received FDA 510(k) clearance on 2017-07-06 under approval number K170399. 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 Endoskeleton TO Interbody Fusion Device (IBD)?

Endoskeleton TO Interbody Fusion Device (IBD) is a medical device that received FDA 510(k) clearance on 2017-07-06. It is manufactured by Titan Spine, LLC. The 510(k) number is K170399.

When was Endoskeleton TO Interbody Fusion Device (IBD) approved by the FDA?

Endoskeleton TO Interbody Fusion Device (IBD) received FDA 510(k) clearance on 2017-07-06, under approval number K170399.

What company makes Endoskeleton TO Interbody Fusion Device (IBD)?

Endoskeleton TO Interbody Fusion Device (IBD) is manufactured by Titan Spine, LLC.

What is the FDA product code for Endoskeleton TO Interbody Fusion Device (IBD)?

The FDA product code for Endoskeleton TO Interbody Fusion Device (IBD) 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: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Titan Spine, LLC

K163269Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device

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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