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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 K220261
Device Name NEST-C Interbody System
Applicant
Paonan Biotech Co., Ltd.
3f, #50, Ln. 258, Rueiguang Rd., Neihu District
Taipei City,  TW 114062
Applicant Contact Penny Huang
Correspondent
Paonan Biotech Co., Ltd.
3f, #50, Ln. 258, Rueiguang Rd., Neihu District
Taipei City,  TW 114062
Correspondent Contact Penny Huang
Regulation Number888.3080
Classification Product Code
ODP  
Date Received01/31/2022
Decision Date 04/24/2023
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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