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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, Lumbar
510(k) Number K180230
Device Name NEST Interbody System
Applicant
Paonan Biotech Co., Ltd.
3f, # 50, Lane 258, Rueiguang Rd.
Neihu District
Taipei City 114,  TW 11491
Applicant Contact Tony Lin
Correspondent
Paonan Biotech Co., Ltd.
3f, # 50, Lane 258, Rueiguang Rd.
Neihu District
Taipei City 114,  TW 11491
Correspondent Contact Tony Lin
Regulation Number888.3080
Classification Product Code
MAX  
Date Received01/26/2018
Decision Date 01/25/2019
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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