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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K242896
Device Name Caliber Intramedullary Fixation System
Applicant
Nvision Biomedical Technologies
4590 Lockhill Selma Rd.
San Antonio,  TX  78249
Applicant Contact Erin Lansdale
Correspondent
Nvision Biomedical Technologies
4590 Lockhill Selma Rd.
San Antonio,  TX  78249
Correspondent Contact Erin Lansdale
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
JDW  
Date Received09/23/2024
Decision Date 02/05/2025
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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