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FDA 510(k)

VISIONAIRE UK Patient Matched Cutting Guides

K-Number: K211512 · 2021-09-16

ApplicantSmith & Nephew, Inc.
Decision Date2021-09-16
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VISIONAIRE UK Patient Matched Cutting Guides is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2021-09-16 under approval number K211512. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISIONAIRE UK Patient Matched Cutting Guides?

VISIONAIRE UK Patient Matched Cutting Guides is a medical device that received FDA 510(k) clearance on 2021-09-16. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K211512.

When was VISIONAIRE UK Patient Matched Cutting Guides approved by the FDA?

VISIONAIRE UK Patient Matched Cutting Guides received FDA 510(k) clearance on 2021-09-16, under approval number K211512.

What company makes VISIONAIRE UK Patient Matched Cutting Guides?

VISIONAIRE UK Patient Matched Cutting Guides is manufactured by Smith & Nephew, Inc..

What is the FDA product code for VISIONAIRE UK Patient Matched Cutting Guides?

The FDA product code for VISIONAIRE UK Patient Matched Cutting Guides is HSX.

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Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

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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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