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FDA 510(k)

SURGICASE CONNECT

K-Number: K113599 · 2012-04-27

ApplicantMaterialise NV
Decision Date2012-04-27
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SURGICASE CONNECT is the device name listed in this FDA 510(k) record. The listed applicant is Materialise NV. It received FDA 510(k) clearance on 2012-04-27 under 510(k) number K113599. 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 CONNECT?

SURGICASE CONNECT is a medical device that received FDA 510(k) clearance on 2012-04-27. The listed applicant is Materialise NV. The 510(k) number is K113599.

When did SURGICASE CONNECT receive FDA 510(k) clearance?

SURGICASE CONNECT received FDA 510(k) clearance on 2012-04-27, under 510(k) number K113599.

Who is the listed applicant for SURGICASE CONNECT?

The FDA 510(k) record lists Materialise NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICASE CONNECT?

The FDA product code for SURGICASE CONNECT 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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