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FDA 510(k)

VySpan™ PCT System

K-Number: K232167 · 2023-09-27

ApplicantVy Spine, LLC
Decision Date2023-09-27
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VySpan™ PCT System is the device name listed in this FDA 510(k) record. The listed applicant is Vy Spine, LLC. It received FDA 510(k) clearance on 2023-09-27 under 510(k) number K232167. 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 2023-09-27. The listed applicant is Vy Spine, LLC. The 510(k) number is K232167.

When did VySpan™ PCT System receive FDA 510(k) clearance?

VySpan™ PCT System received FDA 510(k) clearance on 2023-09-27, under 510(k) number K232167.

Who is the listed applicant for VySpan™ PCT System?

The FDA 510(k) record lists Vy Spine, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VySpan™ PCT System?

The FDA product code for VySpan™ PCT System is NKG.

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Related Devices (Code: NKG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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