VyLink Spinal Screw System
K-Number: K213750 · 2022-02-28
ApplicantVy Spine, LLC
Decision Date2022-02-28
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
VyLink Spinal Screw System is a medical device manufactured by Vy Spine, LLC. It received FDA 510(k) clearance on 2022-02-28 under approval number K213750. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VyLink Spinal Screw System?
VyLink Spinal Screw System is a medical device that received FDA 510(k) clearance on 2022-02-28. It is manufactured by Vy Spine, LLC. The 510(k) number is K213750.
When was VyLink Spinal Screw System approved by the FDA?
VyLink Spinal Screw System received FDA 510(k) clearance on 2022-02-28, under approval number K213750.
What company makes VyLink Spinal Screw System?
VyLink Spinal Screw System is manufactured by Vy Spine, LLC.
What is the FDA product code for VyLink Spinal Screw System?
The FDA product code for VyLink Spinal Screw System is NKB.
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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.