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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K250893
Device Name Ball Joint Guide Array (66295)
Applicant
Bayer Medical Care, Inc.
1 Bayer Dr.
Indianaola,  PA  15051
Applicant Contact Purva Pandya
Correspondent
Bayer Medical Care, Inc.
1 Bayer Dr.
Indianaola,  PA  15051
Correspondent Contact Purva Pandya
Regulation Number882.4560
Classification Product Code
HAW  
Date Received03/25/2025
Decision Date 09/04/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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