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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 the device name listed in this FDA 510(k) record. The listed applicant is Meditech Spine, LLC. It received FDA 510(k) clearance on 2020-09-11 under 510(k) 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. The listed applicant is Meditech Spine, LLC. The 510(k) number is K201506.

When did Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System receive FDA 510(k) clearance?

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 510(k) number K201506.

Who is the listed applicant for Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System?

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

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

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.

NCT07593872XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung CancerNOT_YET_RECRUITINGNCT07739979Radiological Outcome of Bony Fusion After Single Level Anterior Cervical Discectomy and Fusion Using Iliac Crest Graft vs. Polyetheretherketone Cage in Cervical SpondylosisCOMPLETED

Related PubMed Literature

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.

PMID: 28256243Mechanical performance of cervical intervertebral body fusion devices: A systematic analysis of data submitted to the Food and Drug Administration.Journal of biomechanics (2017)

Other records listing Meditech 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.

K210286Cure 2.0 Anterior Cervical Plate (ACP) SystemK201136Cure™ Lumbar Plate SystemK181543Cure™ OPEL-C Plate SystemK180090Cure™ Lumbar Plate SystemK171538Cure™ Lumbar Plate SystemK170395Talos® Lumbar (HA) PEEK IBF Devices

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Related Devices (Code: ODP)

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.

K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, 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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