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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 the device name listed in this FDA 510(k) record. The listed applicant is Amendia, Inc.. It received FDA 510(k) clearance on 2016-01-14 under 510(k) 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. The listed applicant is Amendia, Inc.. The 510(k) number is K152972.

When did Amendia Stand-Alone Cervical System receive FDA 510(k) clearance?

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

Who is the listed applicant for Amendia Stand-Alone Cervical System?

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

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 records listing Amendia, Inc. 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.

K160924Amendia Interbody Fusion DevicesK161842Overwatch Spine SystemK152920Savannah-T® Pedicle Screw SystemK153152Syzygy Stabilization SystemK160291Optimus ALIF SystemK151310Amendia Interbody Fusion Devices

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Related Devices (Code: OVE)

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.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

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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