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FDA 510(k)

3Shape Implant Studio

K-Number: K202256 · 2020-09-09

Applicant3Shape Medical A/S
Decision Date2020-09-09
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3Shape Implant Studio is a medical device manufactured by 3Shape Medical A/S. It received FDA 510(k) clearance on 2020-09-09 under approval number K202256. 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 3Shape Implant Studio?

3Shape Implant Studio is a medical device that received FDA 510(k) clearance on 2020-09-09. It is manufactured by 3Shape Medical A/S. The 510(k) number is K202256.

When was 3Shape Implant Studio approved by the FDA?

3Shape Implant Studio received FDA 510(k) clearance on 2020-09-09, under approval number K202256.

What company makes 3Shape Implant Studio?

3Shape Implant Studio is manufactured by 3Shape Medical A/S.

What is the FDA product code for 3Shape Implant Studio?

The FDA product code for 3Shape Implant Studio is LLZ.

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Official Source

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