FDA 510(k)

MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System

N.º K: K254087 · 2026-06-11

Fecha de decisión2026-06-11

Código de productoKTT

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a Synthes (USA) Products, LLC como solicitante

K212943SyntheCel Dura Repair K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)K210408DePuy Synthes Variable Angle Locking Patella Plating System K210205DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System K201346DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm K192702DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional

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Fuente oficial

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