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FDA 510(k)

Biolign® Roto-Loc Cervical Plate System

K-Number: K200523 · 2020-04-30

ApplicantElite Surgical Supplies (Pty), Ltd.
Decision Date2020-04-30
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Biolign® Roto-Loc Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Elite Surgical Supplies (Pty), Ltd.. It received FDA 510(k) clearance on 2020-04-30 under 510(k) number K200523. 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 Biolign® Roto-Loc Cervical Plate System?

Biolign® Roto-Loc Cervical Plate System is a medical device that received FDA 510(k) clearance on 2020-04-30. The listed applicant is Elite Surgical Supplies (Pty), Ltd.. The 510(k) number is K200523.

When did Biolign® Roto-Loc Cervical Plate System receive FDA 510(k) clearance?

Biolign® Roto-Loc Cervical Plate System received FDA 510(k) clearance on 2020-04-30, under 510(k) number K200523.

Who is the listed applicant for Biolign® Roto-Loc Cervical Plate System?

The FDA 510(k) record lists Elite Surgical Supplies (Pty), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biolign® Roto-Loc Cervical Plate System?

The FDA product code for Biolign® Roto-Loc Cervical Plate System is KWQ.

Related Devices (Code: KWQ)

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.

K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLCK260015ANTERIS Thoracolumbar Plate SystemSpineCraft

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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