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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 the device name listed in this FDA 510(k) record. The listed applicant is Elevation Spine. It received FDA 510(k) clearance on 2019-08-07 under 510(k) 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. The listed applicant is Elevation Spine. The 510(k) number is K190885.

When did Elevation Spine Saber-C System receive FDA 510(k) clearance?

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

Who is the listed applicant for Elevation Spine Saber-C System?

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

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

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

Other records listing Elevation Spine 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.

K261408SABER-XA SystemK260660SABER-C SystemK250540SABER-C System

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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