FDA 510(k)

Genesys Spine Apache® Lateral Lumbar Interbody Fusion System

K-Number: K161404 · 2016-07-21

Decision Date2016-07-21

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Genesys Spine Apache® Lateral Lumbar Interbody Fusion System is a medical device manufactured by Genesys Spine. It received FDA 510(k) clearance on 2016-07-21 under approval number K161404. 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 Genesys Spine Apache® Lateral Lumbar Interbody Fusion System?

Genesys Spine Apache® Lateral Lumbar Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2016-07-21. It is manufactured by Genesys Spine. The 510(k) number is K161404.

When was Genesys Spine Apache® Lateral Lumbar Interbody Fusion System approved by the FDA?

Genesys Spine Apache® Lateral Lumbar Interbody Fusion System received FDA 510(k) clearance on 2016-07-21, under approval number K161404.

What company makes Genesys Spine Apache® Lateral Lumbar Interbody Fusion System?

Genesys Spine Apache® Lateral Lumbar Interbody Fusion System is manufactured by Genesys Spine.

What is the FDA product code for Genesys Spine Apache® Lateral Lumbar Interbody Fusion System?

The FDA product code for Genesys Spine Apache® Lateral Lumbar Interbody Fusion System is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT07606729 AI-Driven Programs for Non-specific Chronic Neck Pain ACTIVE_NOT_RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_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) PMID: 37504879 Comparative Evaluation of Mineralized Bone Allografts for Spinal Fusion Surgery. Journal of functional biomaterials (2023) PMID: 36074993 Reported Events Associated With Spine Robots: An Analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience Database. Global spine journal (2023)

Other Devices by Genesys Spine

K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion System K161914Genesys Spine TiLock Cortical Spinal System K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion System K153123Genesys Spine Apache Interbody Fusion System K172469TiLock Modular Spinal System K171838TiLock2 Spinal System

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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.