FDA 510(k)

Patient Specific Planning Solution 3D Bone Models

K-Number: K230540 · 2023-07-25

Decision Date2023-07-25

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Patient Specific Planning Solution 3D Bone Models is a medical device manufactured by Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2023-07-25 under approval number K230540. 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 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. It is manufactured by Biomet Manufacturing Corp. The 510(k) number is K230540.

When was Patient Specific Planning Solution 3D Bone Models approved by the FDA?

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

What company makes Patient Specific Planning Solution 3D Bone Models?

Patient Specific Planning Solution 3D Bone Models is manufactured by Biomet Manufacturing Corp.

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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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.