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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 a medical device manufactured by Camber Spine Technologies, LLC. It received FDA 510(k) clearance on 2022-09-02 under approval 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. It is manufactured by Camber Spine Technologies, LLC. The 510(k) number is K203503.

When was Camber Sacroiliac (SI) Fixation System approved by the FDA?

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

What company makes Camber Sacroiliac (SI) Fixation System?

Camber Sacroiliac (SI) Fixation System is manufactured by Camber Spine Technologies, LLC.

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

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

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07245719 Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up COMPLETED NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING NCT05367505 Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the Pelvis RECRUITING

Other Devices by Camber Spine Technologies, LLC

K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System K180724SPIRA Open Matrix LLIF K191584FORTICO Anterior Cervical Fixation System K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers K232256Alcantara Thoracolumbar Plate System

Related Devices (Code: OUR)

K161755Integrity-SI TM Fusion SystemCoorstek Medical K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd. K161210RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) SystemsMedtronic Sofamor Danek K160652iFUSE Implant SystemSI-BONE, Inc. K152681iFuse Implant System(R)SI-BONE, Inc. K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC

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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