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FDA 510(k)

ALTA Anterior Cervical Interbody Spacer

K-Number: K173324 · 2018-02-27

ApplicantAstura Medical
Decision Date2018-02-27
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ALTA Anterior Cervical Interbody Spacer is a medical device manufactured by Astura Medical. It received FDA 510(k) clearance on 2018-02-27 under approval number K173324. 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 ALTA Anterior Cervical Interbody Spacer?

ALTA Anterior Cervical Interbody Spacer is a medical device that received FDA 510(k) clearance on 2018-02-27. It is manufactured by Astura Medical. The 510(k) number is K173324.

When was ALTA Anterior Cervical Interbody Spacer approved by the FDA?

ALTA Anterior Cervical Interbody Spacer received FDA 510(k) clearance on 2018-02-27, under approval number K173324.

What company makes ALTA Anterior Cervical Interbody Spacer?

ALTA Anterior Cervical Interbody Spacer is manufactured by Astura Medical.

What is the FDA product code for ALTA Anterior Cervical Interbody Spacer?

The FDA product code for ALTA Anterior Cervical Interbody Spacer is ODP.

Related Clinical Trials

NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING 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 NCT04214535 Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels ACTIVE_NOT_RECRUITING

Other Devices by Astura Medical

K160702ZION Anterior Cervical Fixation System K160154ALTA Anterior Cervical Interbody Spacer K153446OLYMPIC Posterior Spinal Fixation System K152512Half Dome Posterior Lumbar Interbody System K171250BRIDALVEIL Occipital Cervical Thoracic System K163481HALF DOME Posterior Lumbar Interbody 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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