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FDA 510(k)

Pantheon Spinal Pontus Interbody Fusion Device

K-Number: K181548 · 2019-12-16

ApplicantPantheon Spinal
Decision Date2019-12-16
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Pantheon Spinal Pontus Interbody Fusion Device is a medical device manufactured by Pantheon Spinal. It received FDA 510(k) clearance on 2019-12-16 under approval number K181548. 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 Pantheon Spinal Pontus Interbody Fusion Device?

Pantheon Spinal Pontus Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2019-12-16. It is manufactured by Pantheon Spinal. The 510(k) number is K181548.

When was Pantheon Spinal Pontus Interbody Fusion Device approved by the FDA?

Pantheon Spinal Pontus Interbody Fusion Device received FDA 510(k) clearance on 2019-12-16, under approval number K181548.

What company makes Pantheon Spinal Pontus Interbody Fusion Device?

Pantheon Spinal Pontus Interbody Fusion Device is manufactured by Pantheon Spinal.

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

The FDA product code for Pantheon Spinal Pontus 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)

Other Devices by Pantheon Spinal

K203003Pantheon IBFD K241494Pantheon Pedicle Screw and Iliac Bolt Fixation System

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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