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FDA 510(k)

ATEC Cervical Spacer System

K-Number: K181435 · 2018-08-21

ApplicantAlphatec Spine, Inc.
Decision Date2018-08-21
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ATEC Cervical Spacer System is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2018-08-21 under approval number K181435. 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 ATEC Cervical Spacer System?

ATEC Cervical Spacer System is a medical device that received FDA 510(k) clearance on 2018-08-21. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K181435.

When was ATEC Cervical Spacer System approved by the FDA?

ATEC Cervical Spacer System received FDA 510(k) clearance on 2018-08-21, under approval number K181435.

What company makes ATEC Cervical Spacer System?

ATEC Cervical Spacer System is manufactured by Alphatec Spine, Inc..

What is the FDA product code for ATEC Cervical Spacer System?

The FDA product code for ATEC Cervical Spacer System is ODP.

Related Clinical Trials

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Other Devices by Alphatec Spine, Inc.

K160646XYcor® Expandable Spinal Spacer System K161363Arsenal Spinal Fixation System K153603Alphatec Navigation Instruments K173522Solanas® Posterior Stabilization System K182746ATEC ALIF and LLIF Spacer System K182808Aspida® Anterior Lumbar Plating System

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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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