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FDA 510(k)

Elevation Spine Saber-C System

K-Number: K190885 · 2019-08-07

ApplicantElevation Spine
Decision Date2019-08-07
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Elevation Spine Saber-C System is a medical device manufactured by Elevation Spine. It received FDA 510(k) clearance on 2019-08-07 under approval number K190885. 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 Elevation Spine Saber-C System?

Elevation Spine Saber-C System is a medical device that received FDA 510(k) clearance on 2019-08-07. It is manufactured by Elevation Spine. The 510(k) number is K190885.

When was Elevation Spine Saber-C System approved by the FDA?

Elevation Spine Saber-C System received FDA 510(k) clearance on 2019-08-07, under approval number K190885.

What company makes Elevation Spine Saber-C System?

Elevation Spine Saber-C System is manufactured by Elevation Spine.

What is the FDA product code for Elevation Spine Saber-C System?

The FDA product code for Elevation Spine Saber-C System is OVE.

Related Clinical Trials

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Other Devices by Elevation Spine

K250540SABER-C System K260660SABER-C 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

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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