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FDA 510(k)

Endoskeleton TCS Interbody Fusion Device

K-Number: K191565 · 2019-08-06

ApplicantTitan Spine, Inc.
Decision Date2019-08-06
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Endoskeleton TCS Interbody Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Titan Spine, Inc.. It received FDA 510(k) clearance on 2019-08-06 under 510(k) number K191565. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endoskeleton TCS Interbody Fusion Device?

Endoskeleton TCS Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2019-08-06. The listed applicant is Titan Spine, Inc.. The 510(k) number is K191565.

When did Endoskeleton TCS Interbody Fusion Device receive FDA 510(k) clearance?

Endoskeleton TCS Interbody Fusion Device received FDA 510(k) clearance on 2019-08-06, under 510(k) number K191565.

Who is the listed applicant for Endoskeleton TCS Interbody Fusion Device?

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

What is the FDA product code for Endoskeleton TCS Interbody Fusion Device?

The FDA product code for Endoskeleton TCS Interbody Fusion Device is OVE.

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.

NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATION

Other records listing Titan Spine, 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.

K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion DeviceK192054Endoskeleton TAS PlateK192018Endoskeleton 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 DeviceK183557Endoskeleton® 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) DeviceK173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion DeviceK170399Endoskeleton TO Interbody Fusion Device (IBD)

View all 8 devices →

Related Devices (Code: OVE)

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.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

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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