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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K243774
Device Name ELID (Endoscopic Less Invasive Decompression) System
Applicant
Lesspine Innovations
200 Summit Dr.
Suite 505
Burlington,  MA  01803
Applicant Contact Vito Lore
Correspondent
Empirical Technologies
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Hannah Taggart
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
HAE  
Date Received12/06/2024
Decision Date 08/27/2025
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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