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FDA 510(k)

SurgiCase Viewer

K-Number: K213684 · 2022-06-15

ApplicantMaterialise NV
Decision Date2022-06-15
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SurgiCase Viewer is a medical device manufactured by Materialise NV. It received FDA 510(k) clearance on 2022-06-15 under approval number K213684. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SurgiCase Viewer?

SurgiCase Viewer is a medical device that received FDA 510(k) clearance on 2022-06-15. It is manufactured by Materialise NV. The 510(k) number is K213684.

When was SurgiCase Viewer approved by the FDA?

SurgiCase Viewer received FDA 510(k) clearance on 2022-06-15, under approval number K213684.

What company makes SurgiCase Viewer?

SurgiCase Viewer is manufactured by Materialise NV.

What is the FDA product code for SurgiCase Viewer?

The FDA product code for SurgiCase Viewer is LLZ.

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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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