510(k) K250893

Ball Joint Guide Array (66295) by Bayer Medical Care, Inc. — Product Code HAW

K250893 is an FDA 510(k) premarket notification submitted by Bayer Medical Care, Inc. for the device "Ball Joint Guide Array (66295)". The FDA issued a decision of Substantially Equivalent on September 4, 2025. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Bayer Medical Care, Inc. has at least 9 other 510(k) clearances on record.