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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Interlaminal
510(k) Number K934860
Device Name TI-FRAME
Applicant
Johnson & Johnson Professionals, Inc.
41 Pacella Park Dr.
Randolph Ind. Park
Randolph,  MA  02368
Applicant Contact AMY WALTERS
Correspondent
Johnson & Johnson Professionals, Inc.
41 Pacella Park Dr.
Randolph Ind. Park
Randolph,  MA  02368
Correspondent Contact AMY WALTERS
Regulation Number888.3050
Classification Product Code
KWP  
Date Received10/12/1993
Decision Date 06/03/1994
Decision Substantially Equivalent (SESE)
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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