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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Cranioplasty, Preformed, Non-Alterable
510(k) Number K252573
Device Name KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE
Applicant
KLS-Martin L.P.
11201 Saint Johns Industrial Pkwy. S
Jacksonville,  FL  32246
Applicant Contact Melissa Bachorski
Correspondent
KLS-Martin L.P.
11201 Saint Johns Industrial Pkwy. S
Jacksonville,  FL  32246
Correspondent Contact Pam Martin
Regulation Number882.5330
Classification Product Code
GXN  
Subsequent Product Codes
GXP   HRS   JEY  
Date Received08/14/2025
Decision Date 11/10/2025
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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