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FDA 510(k)

Endoskeleton TAS Plate

K-Number: K192054 · 2019-08-29

ApplicantTitan Spine, Inc.
Decision Date2019-08-29
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Endoskeleton TAS Plate is a medical device manufactured by Titan Spine, Inc.. It received FDA 510(k) clearance on 2019-08-29 under approval number K192054. 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 Endoskeleton TAS Plate?

Endoskeleton TAS Plate is a medical device that received FDA 510(k) clearance on 2019-08-29. It is manufactured by Titan Spine, Inc.. The 510(k) number is K192054.

When was Endoskeleton TAS Plate approved by the FDA?

Endoskeleton TAS Plate received FDA 510(k) clearance on 2019-08-29, under approval number K192054.

What company makes Endoskeleton TAS Plate?

Endoskeleton TAS Plate is manufactured by Titan Spine, Inc..

What is the FDA product code for Endoskeleton TAS Plate?

The FDA product code for Endoskeleton TAS Plate is OVD.

Related Clinical Trials

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

Other Devices by Titan Spine, Inc.

K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device K191565Endoskeleton TCS Interbody Fusion Device K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device

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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