FDA 510(k)

ENZA-A Titanium ALIF

K-Number: K173432 · 2018-04-18

Decision Date2018-04-18

Product CodeOVD

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ENZA-A Titanium ALIF is a medical device manufactured by Camber Spine Technologies. It received FDA 510(k) clearance on 2018-04-18 under approval number K173432. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENZA-A Titanium ALIF?

ENZA-A Titanium ALIF is a medical device that received FDA 510(k) clearance on 2018-04-18. It is manufactured by Camber Spine Technologies. The 510(k) number is K173432.

When was ENZA-A Titanium ALIF approved by the FDA?

ENZA-A Titanium ALIF received FDA 510(k) clearance on 2018-04-18, under approval number K173432.

What company makes ENZA-A Titanium ALIF?

ENZA-A Titanium ALIF is manufactured by Camber Spine Technologies.

What is the FDA product code for ENZA-A Titanium ALIF?

The FDA product code for ENZA-A Titanium ALIF is OVD.

Other Devices by Camber Spine Technologies

K153720ENZA Zero-Profile Anterior Interbody Fusion K172446SPIRA-C Open Matrix Cervical Interbody K172064Ti-Diagon Oblique TLIF K170550Coveris Cervical Cage System K162986SPIRA Open Matrix ALIF K162121Siconus SI Joint Fixation System

View all 16 devices →

Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu aPOD Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, 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.