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FDA 510(k)

Amendia Stand-Alone Cervical System

K-Number: K152972 · 2016-01-14

ApplicantAmendia, Inc.
Decision Date2016-01-14
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Amendia Stand-Alone Cervical System is a medical device manufactured by Amendia, Inc.. It received FDA 510(k) clearance on 2016-01-14 under approval number K152972. 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 Amendia Stand-Alone Cervical System?

Amendia Stand-Alone Cervical System is a medical device that received FDA 510(k) clearance on 2016-01-14. It is manufactured by Amendia, Inc.. The 510(k) number is K152972.

When was Amendia Stand-Alone Cervical System approved by the FDA?

Amendia Stand-Alone Cervical System received FDA 510(k) clearance on 2016-01-14, under approval number K152972.

What company makes Amendia Stand-Alone Cervical System?

Amendia Stand-Alone Cervical System is manufactured by Amendia, Inc..

What is the FDA product code for Amendia Stand-Alone Cervical System?

The FDA product code for Amendia Stand-Alone Cervical System is OVE.

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Other Devices by Amendia, Inc.

K160924Amendia Interbody Fusion Devices K161842Overwatch Spine System K152920Savannah-T® Pedicle Screw System K153152Syzygy Stabilization System K160291Optimus ALIF System K151310Amendia Interbody Fusion Devices

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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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