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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Fixation Cerclage, Sublaminar
510(k) Number K200281
Device Name The Gecko Spinal System
Applicant
Ortho Development Corporation
12187 S. Business Park Dr.
Draper,  UT  84020
Applicant Contact Divya Palan
Correspondent
Ortho Development Corporation
12187 S. Business Park Dr.
Draper,  UT  84020
Correspondent Contact Divya Palan
Regulation Number888.3010
Classification Product Code
OWI  
Date Received02/04/2020
Decision Date 03/31/2020
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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