Euroscrew NG; Euroscrew TCP NG

FDA 510(k) K230394 · Teknimed

Substantially Equivalent

510(k) numberK230394

Submission

Device name
Euroscrew NG; Euroscrew TCP NG
Applicant
Teknimed
L'Union, FR
Received
February 14, 2023
Decision date
May 12, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MAI – Fastener, Fixation, Biodegradable, Soft Tissue
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Specialty
Orthopedic
Implant
Yes

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K260294SF Push-in AnchorMAI · Traditional Surgical Fusion Technologies GmbH03/27/2026SE
K254055OSSIOfiber® Suture AnchorMAI · Traditional OSSIO , Ltd.02/24/2026SE
K251680Biosteon® ScrewMAI · Traditional Biocomposites, Ltd.02/17/2026SE
K252946BioBrace® Extra-Articular Ligament Augmentation KitMAI · Special Conmed Corporation10/15/2025SE
K252022OSSIOfiber® Interference ScrewMAI · Traditional OSSIO , Ltd.08/19/2025SE
K251309OSSIOfiber® Suture AnchorMAI · Special OSSIO , Ltd.05/27/2025SE
K250544Knotilus+ Biocomposite Knotless AnchorMAI · Traditional Stryker Endoscopy05/23/2025SE
K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorMAI · Traditional Stryker Endoscopy05/21/2025SE

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Questions and answers

When was Euroscrew NG; Euroscrew TCP NG cleared by the FDA?

Euroscrew NG; Euroscrew TCP NG (K230394) received a 510(k) decision of Substantially Equivalent on May 12, 2023, 87 days after the submission was received.

What is the product code of K230394?

The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.