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FDA 510(k)

SURGICASE ORTHOGNATHIC SOFTWARE WIZARD

K-Number: K111641 · 2011-09-26

ApplicantMaterialise NV
Decision Date2011-09-26
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SURGICASE ORTHOGNATHIC SOFTWARE WIZARD is the device name listed in this FDA 510(k) record. The listed applicant is Materialise NV. It received FDA 510(k) clearance on 2011-09-26 under 510(k) number K111641. 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 ORTHOGNATHIC SOFTWARE WIZARD?

SURGICASE ORTHOGNATHIC SOFTWARE WIZARD is a medical device that received FDA 510(k) clearance on 2011-09-26. The listed applicant is Materialise NV. The 510(k) number is K111641.

When did SURGICASE ORTHOGNATHIC SOFTWARE WIZARD receive FDA 510(k) clearance?

SURGICASE ORTHOGNATHIC SOFTWARE WIZARD received FDA 510(k) clearance on 2011-09-26, under 510(k) number K111641.

Who is the listed applicant for SURGICASE ORTHOGNATHIC SOFTWARE WIZARD?

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 ORTHOGNATHIC SOFTWARE WIZARD?

The FDA product code for SURGICASE ORTHOGNATHIC SOFTWARE WIZARD 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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