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FDA 510(k)

TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES

K-Number: K122850 · 2013-03-28

ApplicantMeditech Advisors, LLC
Decision Date2013-03-28
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Meditech Advisors, LLC. It received FDA 510(k) clearance on 2013-03-28 under 510(k) number K122850. 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 DEVICES?

TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES is a medical device that received FDA 510(k) clearance on 2013-03-28. The listed applicant is Meditech Advisors, LLC. The 510(k) number is K122850.

When did TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES receive FDA 510(k) clearance?

TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES received FDA 510(k) clearance on 2013-03-28, under 510(k) number K122850.

Who is the listed applicant for TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES?

The FDA 510(k) record lists Meditech Advisors, 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 DEVICES?

The FDA product code for TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES is ODP.

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Other records listing Meditech Advisors, 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.

K090707TALOS INTERVERTEBRAL BODY FUSION DEVICE

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.

K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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