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FDA 510(k)

Spinal Jaxx Interbody Fusion Device

K-Number: K152501 · 2016-06-29

ApplicantNeuropro Spinaljaxx, Inc.
Decision Date2016-06-29
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Spinal Jaxx Interbody Fusion Device is a medical device manufactured by Neuropro Spinaljaxx, Inc.. It received FDA 510(k) clearance on 2016-06-29 under approval number K152501. 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 Spinal Jaxx Interbody Fusion Device?

Spinal Jaxx Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2016-06-29. It is manufactured by Neuropro Spinaljaxx, Inc.. The 510(k) number is K152501.

When was Spinal Jaxx Interbody Fusion Device approved by the FDA?

Spinal Jaxx Interbody Fusion Device received FDA 510(k) clearance on 2016-06-29, under approval number K152501.

What company makes Spinal Jaxx Interbody Fusion Device?

Spinal Jaxx Interbody Fusion Device is manufactured by Neuropro Spinaljaxx, Inc..

What is the FDA product code for Spinal Jaxx Interbody Fusion Device?

The FDA product code for Spinal Jaxx Interbody Fusion Device is MAX.

Related Clinical Trials

NCT06998134 Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults RECRUITING NCT07615491 PMCF Study on the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07610850 Brain-controlled Spinal Cord Stimulation in Participants With Chronic Stroke for Lower and Upper Limb Rehabilitation NOT_YET_RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) 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: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026) PMID: 40003250 Bridging the Gap in FDA Approval for Pediatric Neuromodulation Devices. Children (Basel, Switzerland) (2025) PMID: 39973146 Characterization of Spine Implant Device Recalls: A 21-Year Analysis. Spine (2026)

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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