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FDA 510(k)

SMG Anterior Cervical Plate System

K-Number: K183073 · 2019-02-11

ApplicantSapphire Medical Group
Decision Date2019-02-11
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMG Anterior Cervical Plate System is a medical device manufactured by Sapphire Medical Group. It received FDA 510(k) clearance on 2019-02-11 under approval number K183073. 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 SMG Anterior Cervical Plate System?

SMG Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2019-02-11. It is manufactured by Sapphire Medical Group. The 510(k) number is K183073.

When was SMG Anterior Cervical Plate System approved by the FDA?

SMG Anterior Cervical Plate System received FDA 510(k) clearance on 2019-02-11, under approval number K183073.

What company makes SMG Anterior Cervical Plate System?

SMG Anterior Cervical Plate System is manufactured by Sapphire Medical Group.

What is the FDA product code for SMG Anterior Cervical Plate System?

The FDA product code for SMG Anterior Cervical Plate System is KWQ.

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Other Devices by Sapphire Medical Group

K172674Sapphire Cervical Implant System K192316Matrix HA PEEK Cervical Implant System K232619MATRIX HA PEEK Cervical IBF 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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