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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cranial Distraction System
510(k) Number K230211
Device Name CranioXpand
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 Daphne Vincent
Regulation Number882.5330
Classification Product Code
PBJ  
Date Received01/26/2023
Decision Date 11/21/2023
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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