FDA 510(k)

Patient Specific Planning Solution™ 3D Bone Models

Número K: K230540 · 2023-07-25

Data da decisão2023-07-25

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Patient Specific Planning Solution™ 3D Bone Models is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2023-07-25 under 510(k) number K230540. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Patient Specific Planning Solution™ 3D Bone Models?

Patient Specific Planning Solution™ 3D Bone Models is a medical device that received FDA 510(k) clearance on 2023-07-25. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K230540.

When did Patient Specific Planning Solution™ 3D Bone Models receive FDA 510(k) clearance?

Patient Specific Planning Solution™ 3D Bone Models received FDA 510(k) clearance on 2023-07-25, under 510(k) number K230540.

Who is the listed applicant for Patient Specific Planning Solution™ 3D Bone Models?

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

What is the FDA product code for Patient Specific Planning Solution™ 3D Bone Models?

The FDA product code for Patient Specific Planning Solution™ 3D Bone Models is LLZ.

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Fonte oficial

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