FDA 510(k)

VySpan PCT System

K-Number: K223852 · 2023-02-24

Decision Date2023-02-24

Product CodeNKG

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

VySpan PCT System is a medical device manufactured by Vy Spine, LLC. It received FDA 510(k) clearance on 2023-02-24 under approval number K223852. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VySpan PCT System?

VySpan PCT System is a medical device that received FDA 510(k) clearance on 2023-02-24. It is manufactured by Vy Spine, LLC. The 510(k) number is K223852.

When was VySpan PCT System approved by the FDA?

VySpan PCT System received FDA 510(k) clearance on 2023-02-24, under approval number K223852.

What company makes VySpan PCT System?

VySpan PCT System is manufactured by Vy Spine, LLC.

What is the FDA product code for VySpan PCT System?

The FDA product code for VySpan PCT System is NKG.

Other Devices by Vy Spine, LLC

K213219Vy Spine VyWasher Buttress System K212715Vy Spine ClariVy Cervical IBF System K213394Vy Spine VySpan PCT System K221162UniVy OsteoVy Cervical IBF System K221572VyPlate Anterior Cervical Plate System K213750VyLink Spinal Screw System

View all 21 devices →

Related Devices (Code: NKG)

K161032neon3 universal OCT spinal stabilizationUlrich GmbH & Co. KG K162300Reform® POCT SystemPrecision Spine, Inc. K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. K161591QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc. K161478Xenco Medical Posterior Cervical SystemXenco Medical, LLC K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, 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.