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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 K240872
Device Name Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System
Applicant
Clariance
18, Rue Robespierre
Beaurains,  FR 62217
Applicant Contact Magalie Hennequin
Correspondent
Clariance, Inc.
42547 Farrington St.
Dallas,  TX  75207
Correspondent Contact Magalie Hennequin
Regulation Number888.3070
Classification Product Code
NKB  
Date Received03/29/2024
Decision Date 04/26/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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