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FDA 510(k)

SURGICASE

K-Number: K073449 · 2008-04-16

ApplicantMaterialise NV
Decision Date2008-04-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SURGICASE is the device name listed in this FDA 510(k) record. The listed applicant is Materialise NV. It received FDA 510(k) clearance on 2008-04-16 under 510(k) number K073449. 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?

SURGICASE is a medical device that received FDA 510(k) clearance on 2008-04-16. The listed applicant is Materialise NV. The 510(k) number is K073449.

When did SURGICASE receive FDA 510(k) clearance?

SURGICASE received FDA 510(k) clearance on 2008-04-16, under 510(k) number K073449.

Who is the listed applicant for SURGICASE?

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?

The FDA product code for SURGICASE is LLZ.

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Other records listing Materialise NV as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerK251964Mimics Thoracic PlannerK253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic ModelsK253793Materialise TKA Guide SystemK251554Materialise TKA Guide SystemK243637Materialise Personalized Guides and Models for Craniomaxillofacial Surgery

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Related Devices (Code: 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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