FDA 510(k)

Ball Joint Guide Array (66295)

N.º K: K250893 · 2025-09-04

Fecha de decisión2025-09-04

Código de productoHAW

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Ball Joint Guide Array (66295) is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Medical Care, Inc.. It received FDA 510(k) clearance on 2025-09-04 under 510(k) number K250893. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Ball Joint Guide Array (66295)?

Ball Joint Guide Array (66295) is a medical device that received FDA 510(k) clearance on 2025-09-04. The listed applicant is Bayer Medical Care, Inc.. The 510(k) number is K250893.

When did Ball Joint Guide Array (66295) receive FDA 510(k) clearance?

Ball Joint Guide Array (66295) received FDA 510(k) clearance on 2025-09-04, under 510(k) number K250893.

Who is the listed applicant for Ball Joint Guide Array (66295)?

The FDA 510(k) record lists Bayer Medical Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ball Joint Guide Array (66295)?

The FDA product code for Ball Joint Guide Array (66295) is HAW.

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Fuente oficial

Ver en la base de datos de la FDA →

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