FDA 510(k)

MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System

Número K: K254087 · 2026-06-11

Data da decisão2026-06-11

Código do produtoKTT

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2026-06-11 under 510(k) number K254087. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System?

MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K254087.

When did MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System receive FDA 510(k) clearance?

MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System received FDA 510(k) clearance on 2026-06-11, under 510(k) number K254087.

Who is the listed applicant for MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System?

The FDA 510(k) record lists Synthes (USA) Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System?

The FDA product code for MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System is KTT.

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Fonte oficial

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