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FDA 510(k)

Rampart One Lumbar Interbody Fusion System

K-Number: K191091 · 2019-05-23

ApplicantSpineology, Inc.
Decision Date2019-05-23
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Rampart One Lumbar Interbody Fusion System is a medical device manufactured by Spineology, Inc.. It received FDA 510(k) clearance on 2019-05-23 under approval number K191091. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rampart One Lumbar Interbody Fusion System?

Rampart One Lumbar Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2019-05-23. It is manufactured by Spineology, Inc.. The 510(k) number is K191091.

When was Rampart One Lumbar Interbody Fusion System approved by the FDA?

Rampart One Lumbar Interbody Fusion System received FDA 510(k) clearance on 2019-05-23, under approval number K191091.

What company makes Rampart One Lumbar Interbody Fusion System?

Rampart One Lumbar Interbody Fusion System is manufactured by Spineology, Inc..

What is the FDA product code for Rampart One Lumbar Interbody Fusion System?

The FDA product code for Rampart One Lumbar Interbody Fusion System is OVD.

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 NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

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 Spineology, Inc.

K160074Rampart D Lumbar Interbody Fusion Device K161694Threshold™ Pedicular Fixation System K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation System K153323Palisade Pedicular Fixation System K153082Rampart A Lumbar Interbody Fusion Device

View all 33 devices →

Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, 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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