FDA 510(k)

3Shape Splint Design

K-Number: K191911 · 2019-11-27

Decision Date2019-11-27

Product CodePNN

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

3Shape Splint Design is a medical device manufactured by 3Shape A/S. It received FDA 510(k) clearance on 2019-11-27 under approval number K191911. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3Shape Splint Design?

3Shape Splint Design is a medical device that received FDA 510(k) clearance on 2019-11-27. It is manufactured by 3Shape A/S. The 510(k) number is K191911.

When was 3Shape Splint Design approved by the FDA?

3Shape Splint Design received FDA 510(k) clearance on 2019-11-27, under approval number K191911.

What company makes 3Shape Splint Design?

3Shape Splint Design is manufactured by 3Shape A/S.

What is the FDA product code for 3Shape Splint Design?

The FDA product code for 3Shape Splint Design is PNN.

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Related Devices (Code: PNN)

K1520863Shape Ortho System3Shape A/S K163677Ortho System3Shape A/S K162850GuideMia Ortho+Guidemia Technologies, LLC K181112Orchestrate 3DOrchestrate 3D K180941Ortho System3Shape A/S K171634Ortho System3Shape A/S

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.