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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 a medical device manufactured by Elite Surgical Supplies (Pty), Ltd.. It received FDA 510(k) clearance on 2020-04-30 under approval 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. It is manufactured by Elite Surgical Supplies (Pty), Ltd.. The 510(k) number is K200523.

When was Biolign® Roto-Loc Cervical Plate System approved by the FDA?

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

What company makes Biolign® Roto-Loc Cervical Plate System?

Biolign® Roto-Loc Cervical Plate System is manufactured by Elite Surgical Supplies (Pty), Ltd..

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.

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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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