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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K243281
Device Name LOCK-IN Spinal Fixation System
Applicant
Lock-In USA Corp
3411 Silverside Rd.
Tatnall Bldg. #104
Wilmington,  DE  19810
Applicant Contact Lacaze Guillaume
Correspondent
Secure BioMed Evaluations
7828 Hickory Flat Hwy Suite 120
Woodstock,  GA  30188
Correspondent Contact Justin Gracyalny
Regulation Number888.3070
Classification Product Code
NKB  
Date Received10/17/2024
Decision Date 12/13/2024
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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