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FDA 510(k)

Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System

K-Number: K201506 · 2020-09-11

ApplicantMeditech Spine, LLC
Decision Date2020-09-11
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System is a medical device manufactured by Meditech Spine, LLC. It received FDA 510(k) clearance on 2020-09-11 under approval number K201506. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System?

Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System is a medical device that received FDA 510(k) clearance on 2020-09-11. It is manufactured by Meditech Spine, LLC. The 510(k) number is K201506.

When was Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System approved by the FDA?

Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System received FDA 510(k) clearance on 2020-09-11, under approval number K201506.

What company makes Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System?

Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System is manufactured by Meditech Spine, LLC.

What is the FDA product code for Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System?

The FDA product code for Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System is ODP.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_RECRUITING NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT06011551 HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs RECRUITING

Related PubMed Literature

PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Meditech Spine, LLC

K160604Cure™ Anterior Cervical Plate (ACP) System K171538Cure™ Lumbar Plate System K170395Talos® Lumbar (HA) PEEK IBF Devices K181543Cure™ OPEL-C Plate System K180090Cure™ Lumbar Plate System K201136Cure™ Lumbar Plate System

View all 8 devices →

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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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