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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical
510(k) Number K230026
Device Name SQUALE
Applicant
Implanet, S.A.
Technopole Bordeaux Montesquieu, Allee Francois Magendie
Martillac,  FR 33650
Applicant Contact Régis Le Couëdic
Correspondent
Hogan Lovells US LLP
1735 Market St.,
23rd Floor
Philadelphia,  PA  19103
Correspondent Contact Kelliann H Payne
Regulation Number888.3080
Classification Product Code
ODP  
Date Received01/04/2023
Decision Date 03/28/2023
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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