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FDA 510(k)

Genesys Spine 3DP Lumbar Interbody System

K-Number: K182987 · 2019-12-12

ApplicantGenesys Spine
Decision Date2019-12-12
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Genesys Spine 3DP Lumbar Interbody System is a medical device manufactured by Genesys Spine. It received FDA 510(k) clearance on 2019-12-12 under approval number K182987. 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 3DP Lumbar Interbody System?

Genesys Spine 3DP Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2019-12-12. It is manufactured by Genesys Spine. The 510(k) number is K182987.

When was Genesys Spine 3DP Lumbar Interbody System approved by the FDA?

Genesys Spine 3DP Lumbar Interbody System received FDA 510(k) clearance on 2019-12-12, under approval number K182987.

What company makes Genesys Spine 3DP Lumbar Interbody System?

Genesys Spine 3DP Lumbar Interbody System is manufactured by Genesys Spine.

What is the FDA product code for Genesys Spine 3DP Lumbar Interbody System?

The FDA product code for Genesys Spine 3DP Lumbar 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 NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) 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 NCT07589023 A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis NOT_YET_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 Genesys Spine

K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion System K161914Genesys Spine TiLock Cortical Spinal System K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion System K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion System K153123Genesys Spine Apache Interbody Fusion System K172469TiLock Modular Spinal System

View all 21 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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