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FDA 510(k)

Alta ACDF System

K-Number: K152622 · 2016-07-08

ApplicantBiomet Spine
Decision Date2016-07-08
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Alta ACDF System is a medical device manufactured by Biomet Spine. It received FDA 510(k) clearance on 2016-07-08 under approval 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. It is manufactured by Biomet Spine. The 510(k) number is K152622.

When was Alta ACDF System approved by the FDA?

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

What company makes Alta ACDF System?

Alta ACDF System is manufactured by Biomet Spine.

What is the FDA product code for Alta ACDF System?

The FDA product code for Alta ACDF System is OVE.

Related Devices (Code: OVE)

K162531STERISPINE CCSafe Orthopaedics K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, 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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