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FDA 510(k)

SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices

K-Number: K190193 · 2019-03-04

ApplicantSpineex, Inc.
Decision Date2019-03-04
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices is a medical device manufactured by Spineex, Inc.. It received FDA 510(k) clearance on 2019-03-04 under approval number K190193. 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 SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices?

SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices is a medical device that received FDA 510(k) clearance on 2019-03-04. It is manufactured by Spineex, Inc.. The 510(k) number is K190193.

When was SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices approved by the FDA?

SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices received FDA 510(k) clearance on 2019-03-04, under approval number K190193.

What company makes SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices?

SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices is manufactured by Spineex, Inc..

What is the FDA product code for SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices?

The FDA product code for SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices 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 Spineex, Inc.

K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices

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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