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FDA 510(k)

SPIRA-C Integrated Fixation System

K-Number: K193153 · 2020-04-24

ApplicantCamber Spine Technologies
Decision Date2020-04-24
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPIRA-C Integrated Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Camber Spine Technologies. It received FDA 510(k) clearance on 2020-04-24 under 510(k) number K193153. 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 SPIRA-C Integrated Fixation System?

SPIRA-C Integrated Fixation System is a medical device that received FDA 510(k) clearance on 2020-04-24. The listed applicant is Camber Spine Technologies. The 510(k) number is K193153.

When did SPIRA-C Integrated Fixation System receive FDA 510(k) clearance?

SPIRA-C Integrated Fixation System received FDA 510(k) clearance on 2020-04-24, under 510(k) number K193153.

Who is the listed applicant for SPIRA-C Integrated Fixation System?

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

What is the FDA product code for SPIRA-C Integrated Fixation System?

The FDA product code for SPIRA-C Integrated Fixation System is OVE.

Other records listing Camber Spine Technologies 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.

K234077SPIRA® Anterior Lumbar SpacersK232256Alcantara Thoracolumbar Plate SystemK233972Camber Sacroiliac (SI) Fixation SystemK230942SPIRA® Posterior Lumbar SpacersK221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)K223837SPIRA®-C Integrated Fixation System

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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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