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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K914804
Device Name RADIUS OSTEOTOMY PLATES
Applicant
Link America, Inc.
C/O Surgical Implants, Inc.
10 Great Meadow Ln.
East Hanavor,  NJ  07936
Applicant Contact MR. E SCHUSSLER
Correspondent
Link America, Inc.
C/O Surgical Implants, Inc.
10 Great Meadow Ln.
East Hanavor,  NJ  07936
Correspondent Contact MR. E SCHUSSLER
Regulation Number888.3030
Classification Product Code
HRS  
Date Received10/24/1991
Decision Date 04/29/1992
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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