FDA 510(k)

Titus Titanium Cervical by SAGICO

K-Number: K221138 · 2023-08-04

Decision Date2023-08-04

Product CodeOVE

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Titus Titanium Cervical by SAGICO is a medical device manufactured by Sagico VA USA, LLC. It received FDA 510(k) clearance on 2023-08-04 under approval number K221138. 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 Titus Titanium Cervical by SAGICO?

Titus Titanium Cervical by SAGICO is a medical device that received FDA 510(k) clearance on 2023-08-04. It is manufactured by Sagico VA USA, LLC. The 510(k) number is K221138.

When was Titus Titanium Cervical by SAGICO approved by the FDA?

Titus Titanium Cervical by SAGICO received FDA 510(k) clearance on 2023-08-04, under approval number K221138.

What company makes Titus Titanium Cervical by SAGICO?

Titus Titanium Cervical by SAGICO is manufactured by Sagico VA USA, LLC.

What is the FDA product code for Titus Titanium Cervical by SAGICO?

The FDA product code for Titus Titanium Cervical by SAGICO is OVE.

Other Devices by Sagico VA USA, LLC

K232561Ripley Spinal Screw System by SAGICO K223143SAGICO Spinal System

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.