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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 K111354
Device Name GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF)
Applicant
GS Medical Co., Ltd.
111 Hill Rd.
P.O. Box 395
Douglassville,  PA  19518
Applicant Contact DONALD W GUTHNER
Correspondent
GS Medical Co., Ltd.
111 Hill Rd.
P.O. Box 395
Douglassville,  PA  19518
Correspondent Contact DONALD W GUTHNER
Regulation Number888.3080
Classification Product Code
MAX  
Date Received05/13/2011
Decision Date 10/17/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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