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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filler, Bone Void, Calcium Compound
510(k) Number K220337
Device Name GaiaBone Bioabsorbable Bone Graft
Applicant
Corliber (Shenzhen) Medical Device Co., Ltd.
#103, Blk 6, 14 Zhongxing Rd., Kengzi Sub-District,
Pingshan District
Shenzhen City,  CN
Applicant Contact Sun Yang
Correspondent
Cosmos Biomed Consulting Co., Ltd.
Rm. 1201, #1, 188 Alley, Shuangliu Rd.
Changning District
Shanghai City,  CN
Correspondent Contact Li-Ting Lu
Regulation Number888.3045
Classification Product Code
MQV  
Date Received02/07/2022
Decision Date 02/03/2023
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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