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FDA 510(k)

ENDOSKELETON TO

K-Number: K102067 · 2010-11-05

ApplicantTitan Spine, LLC
Decision Date2010-11-05
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENDOSKELETON TO 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 2010-11-05 under 510(k) number K102067. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSKELETON TO?

ENDOSKELETON TO is a medical device that received FDA 510(k) clearance on 2010-11-05. The listed applicant is Titan Spine, LLC. The 510(k) number is K102067.

When did ENDOSKELETON TO receive FDA 510(k) clearance?

ENDOSKELETON TO received FDA 510(k) clearance on 2010-11-05, under 510(k) number K102067.

Who is the listed applicant for ENDOSKELETON TO?

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 TO?

The FDA product code for ENDOSKELETON TO is MAX.

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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 DeviceK111626ENDOSKELETON(R) TASK100889ENDOSKELETON TCK083714ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD)

View all 8 devices →

Related Devices (Code: MAX)

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.

K261049SCALA® TLSpineart SAK261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.

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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