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FDA 510(k)

Camber Sacroiliac (SI) Fixation System

K-Number: K203503 · 2022-09-02

ApplicantCamber Spine Technologies, LLC
Decision Date2022-09-02
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Camber Sacroiliac (SI) Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Camber Spine Technologies, LLC. It received FDA 510(k) clearance on 2022-09-02 under 510(k) number K203503. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Camber Sacroiliac (SI) Fixation System?

Camber Sacroiliac (SI) Fixation System is a medical device that received FDA 510(k) clearance on 2022-09-02. The listed applicant is Camber Spine Technologies, LLC. The 510(k) number is K203503.

When did Camber Sacroiliac (SI) Fixation System receive FDA 510(k) clearance?

Camber Sacroiliac (SI) Fixation System received FDA 510(k) clearance on 2022-09-02, under 510(k) number K203503.

Who is the listed applicant for Camber Sacroiliac (SI) Fixation System?

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

What is the FDA product code for Camber Sacroiliac (SI) Fixation System?

The FDA product code for Camber Sacroiliac (SI) Fixation System is OUR.

Other records listing Camber Spine Technologies, LLC 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: OUR)

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.

K260477CATAMARAN™ SI Joint Fusion SystemTenon MedicalK253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.K253611Falco Fusion SystemMcnicoll Surgical, Inc.K252834Sacroiliac Joint Truss System (SJTS)4Web MedicalK251365OptumSI Implant SystemSi Solutions, LLCK252322SIros-X SystemGenesys 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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