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FDA 510(k)

White Pearl Preferred Angle Anterior Cervical Plate

K-Number: K160522 · 2016-04-26

ApplicantOsseus Fusion Systems, LLC
Decision Date2016-04-26
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

White Pearl Preferred Angle Anterior Cervical Plate is a medical device manufactured by Osseus Fusion Systems, LLC. It received FDA 510(k) clearance on 2016-04-26 under approval number K160522. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the White Pearl Preferred Angle Anterior Cervical Plate?

White Pearl Preferred Angle Anterior Cervical Plate is a medical device that received FDA 510(k) clearance on 2016-04-26. It is manufactured by Osseus Fusion Systems, LLC. The 510(k) number is K160522.

When was White Pearl Preferred Angle Anterior Cervical Plate approved by the FDA?

White Pearl Preferred Angle Anterior Cervical Plate received FDA 510(k) clearance on 2016-04-26, under approval number K160522.

What company makes White Pearl Preferred Angle Anterior Cervical Plate?

White Pearl Preferred Angle Anterior Cervical Plate is manufactured by Osseus Fusion Systems, LLC.

What is the FDA product code for White Pearl Preferred Angle Anterior Cervical Plate?

The FDA product code for White Pearl Preferred Angle Anterior Cervical Plate is KWQ.

Related Clinical Trials

NCT07593781 rESWT vs LLLT for Cervical Myofascial Pain COMPLETED NCT07336173 Uterine Artery Doppler Indices and Uterocervical Angle Measurment in Prediction of Preterm Labor RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_RECRUITING NCT07574554 Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation ACTIVE_NOT_RECRUITING NCT07544849 A Randomized Split-Mouth Clinical Trial Comparing Resin Infiltration and Microabrasion for Early Caries Lesions COMPLETED

Other Devices by Osseus Fusion Systems, LLC

K170844Gemini-C Hybrid Cervical Interbody System K181347Aries® Lumbar Interbodies K213590Blue Topaz Sacroiliac Screw System

Related Devices (Code: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, 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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