FDA 510(k)

Alta ACDF System

K-Number: K152622 · 2016-07-08

Decision Date2016-07-08

Product CodeOVE

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Alta ACDF System is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Spine. It received FDA 510(k) clearance on 2016-07-08 under 510(k) number K152622. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Alta ACDF System?

Alta ACDF System is a medical device that received FDA 510(k) clearance on 2016-07-08. The listed applicant is Biomet Spine. The 510(k) number is K152622.

When did Alta ACDF System receive FDA 510(k) clearance?

Alta ACDF System received FDA 510(k) clearance on 2016-07-08, under 510(k) number K152622.

Who is the listed applicant for Alta ACDF System?

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

What is the FDA product code for Alta ACDF System?

The FDA product code for Alta ACDF System is OVE.

Other records listing Biomet Spine 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.

K153695Biomet Spine Fusion System

Related Devices (Code: OVE)

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution Spine K261279DeltaNEC Interbody SystemNexus Spine K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

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.