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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 K262075
Device Name Lapidus Screw Kit
Applicant
Relja Innovations, LLC
11220 W. Burleigh St.
Wauwatosa,  WI  53222
Applicant Contact Robby Amiot
Correspondent
MRC Global
9160 Hwy. 64 Suite 12
P.O. Box 330
Lakeland,  TN  38002
Correspondent Contact Jen McBride
Regulation Number888.3040
Classification Product Code
HWC  
Date Received06/22/2026
Decision Date 07/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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