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FDA 510(k)

ENDOSKELETON(R) TAS

K-Number: K111626 · 2011-09-09

ApplicantTitan Spine, LLC
Decision Date2011-09-09
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENDOSKELETON(R) TAS is the device name listed in this FDA 510(k) record. The listed applicant is Titan Spine, LLC. It received FDA 510(k) clearance on 2011-09-09 under 510(k) number K111626. 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(R) TAS?

ENDOSKELETON(R) TAS is a medical device that received FDA 510(k) clearance on 2011-09-09. The listed applicant is Titan Spine, LLC. The 510(k) number is K111626.

When did ENDOSKELETON(R) TAS receive FDA 510(k) clearance?

ENDOSKELETON(R) TAS received FDA 510(k) clearance on 2011-09-09, under 510(k) number K111626.

Who is the listed applicant for ENDOSKELETON(R) TAS?

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

What is the FDA product code for ENDOSKELETON(R) TAS?

The FDA product code for ENDOSKELETON(R) TAS is OVD.

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Other records listing Titan Spine, LLC 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.

K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion DeviceK170399Endoskeleton TO Interbody Fusion Device (IBD)K163269Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion DeviceK102067ENDOSKELETON TOK100889ENDOSKELETON TCK083714ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD)

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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.

K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF SystemINNO Holdings Inc. DBA InnovasisK261408SABER-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.

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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