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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Bone, Vertebroplasty
510(k) Number K251896
Device Name XeliteMed SuperM-Fix Spinal Bone Cement
Applicant
Xelite Biomed , Ltd.
2f., # 9, Aly. 2, Siwei Ln., Zhongzheng Rd., Xindian Dist.
New Taipei City,  TW 231
Applicant Contact Wei Chun Chang
Correspondent
Xelite Biomed , Ltd.
2f., # 9, Aly. 2, Siwei Ln., Zhongzheng Rd., Xindian Dist.
New Taipei City,  TW 231
Correspondent Contact Wei Chun Chang
Regulation Number888.3027
Classification Product Code
NDN  
Date Received06/20/2025
Decision Date 01/28/2026
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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