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FDA 510(k)

Rampart™ One Lumbar Interbody Fusion System

K-Number: K192047 · 2019-08-23

ApplicantSpineology, Inc.
Decision Date2019-08-23
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Rampart™ One Lumbar Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Spineology, Inc.. It received FDA 510(k) clearance on 2019-08-23 under 510(k) number K192047. 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 2019-08-23. The listed applicant is Spineology, Inc.. The 510(k) number is K192047.

When did Rampart™ One Lumbar Interbody Fusion System receive FDA 510(k) clearance?

Rampart™ One Lumbar Interbody Fusion System received FDA 510(k) clearance on 2019-08-23, under 510(k) number K192047.

Who is the listed applicant for Rampart™ One Lumbar Interbody Fusion System?

The FDA 510(k) record lists Spineology, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05583864Lumbar Fusion With Porous Versus Non-Porous CagesACTIVE_NOT_RECRUITINGNCT07222787Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion OutcomesRECRUITINGNCT07777718Lumbar Fusion With Nanotube Versus Titanium CageNOT_YET_RECRUITINGNCT048238583Spine Lumbar Fusion Real World Evidence StudyACTIVE_NOT_RECRUITINGNCT05237908Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK CagesACTIVE_NOT_RECRUITINGNCT05438719MOTUS Total Joint Replacement Investigational Device Exemption StudyACTIVE_NOT_RECRUITING

Other records listing Spineology, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemK251943Spineology Navigation InstrumentsK230927OptiMesh Multiplanar Expandable Interbody Fusion SystemK231781OptiMesh Multiplanar Expandable Interbody Fusion SystemK213876Spineology Navigation InstrumentsK210155Duo Expandable Interbody Fusion System

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Related Devices (Code: OVD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.K253401SCRIPT™ Implant SystemGlobus Medical, 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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