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FDA 510(k)

AccuFit Lateral 2-Hole Plate

K-Number: K220324 · 2022-03-16

ApplicantPrecision Spine, Inc.
Decision Date2022-03-16
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AccuFit Lateral 2-Hole Plate is a medical device manufactured by Precision Spine, Inc.. It received FDA 510(k) clearance on 2022-03-16 under approval number K220324. 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 2-Hole Plate?

AccuFit Lateral 2-Hole Plate is a medical device that received FDA 510(k) clearance on 2022-03-16. It is manufactured by Precision Spine, Inc.. The 510(k) number is K220324.

When was AccuFit Lateral 2-Hole Plate approved by the FDA?

AccuFit Lateral 2-Hole Plate received FDA 510(k) clearance on 2022-03-16, under approval number K220324.

What company makes AccuFit Lateral 2-Hole Plate?

AccuFit Lateral 2-Hole Plate is manufactured by Precision Spine, Inc..

What is the FDA product code for AccuFit Lateral 2-Hole Plate?

The FDA product code for AccuFit Lateral 2-Hole Plate is KWQ.

Other Devices by Precision Spine, Inc.

K161809ShurFit CpTi-HA ACIF Interbody Fusion System K162211AccuFit Lateral Plate System K162300Reform® POCT System K160568Precision Spine Interspinous Plate System K173130Reform® Midline Cortical Screw System K171657ShurFit 2C Lumbar Interbody Fusion 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 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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