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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K111883
Device Name SMARTLOC SPINAL FIXATION SYSTEM
Applicant
A-Spine Asia, Co., Ltd.
11f., # 1, Aly. 30, Ln. 358
Ruiguang Rd.
Taipei, Neihu District,  TW 11492
Applicant Contact FRANK HSU
Correspondent
A-Spine Asia, Co., Ltd.
11f., # 1, Aly. 30, Ln. 358
Ruiguang Rd.
Taipei, Neihu District,  TW 11492
Correspondent Contact FRANK HSU
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received07/01/2011
Decision Date 10/18/2011
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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