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FDA 510(k)

AccuFit Lateral Plate System

K-Number: K162211 · 2016-11-28

ApplicantPrecision Spine, Inc.
Decision Date2016-11-28
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AccuFit Lateral Plate System is a medical device manufactured by Precision Spine, Inc.. It received FDA 510(k) clearance on 2016-11-28 under approval number K162211. 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 AccuFit Lateral Plate System?

AccuFit Lateral Plate System is a medical device that received FDA 510(k) clearance on 2016-11-28. It is manufactured by Precision Spine, Inc.. The 510(k) number is K162211.

When was AccuFit Lateral Plate System approved by the FDA?

AccuFit Lateral Plate System received FDA 510(k) clearance on 2016-11-28, under approval number K162211.

What company makes AccuFit Lateral Plate System?

AccuFit Lateral Plate System is manufactured by Precision Spine, Inc..

What is the FDA product code for AccuFit Lateral Plate System?

The FDA product code for AccuFit Lateral Plate System is KWQ.

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Other Devices by Precision Spine, Inc.

K161809ShurFit CpTi-HA ACIF Interbody Fusion System K162300Reform® POCT System K160568Precision Spine Interspinous Plate System K173130Reform® Midline Cortical Screw System K171657ShurFit 2C Lumbar Interbody Fusion System K172495Reform® POCT System

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Related Devices (Code: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, Inc. K161524Tangis Anterior Cervical PlateNvision Biomedical Technologies, 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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