3Shape Splint Design
K-Number: K191911 · 2019-11-27
Device Summary
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. The listed applicant is 3Shape A/S. The 510(k) number is K191911.
When did 3Shape Splint Design receive FDA 510(k) clearance?
3Shape Splint Design received FDA 510(k) clearance on 2019-11-27, under 510(k) number K191911.
Who is the listed applicant for 3Shape Splint Design?
The FDA 510(k) record lists 3Shape A/S as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 3Shape Splint Design?
The FDA product code for 3Shape Splint Design is PNN.
Other records listing 3Shape A/S 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.
Related Devices (Code: PNN)
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.
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.