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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K243809
Device Name Biolox® Delta Revision heads
Applicant
Limacorporate
Via Nazionale 52
Villanova Di San Daniele Del Friuli,  IT 33038
Applicant Contact Alessia Collarini
Correspondent
Enovis
Via Nazionale, 52
Villanova Di San Daniele Del Friuli,  IT
Correspondent Contact Alessia Collarini
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
LPH  
Date Received12/11/2024
Decision Date 03/04/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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