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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 Intervertebral Body
510(k) Number K020244
Device Name SYNTHES THORACOLUMBAR SPINE LOCKING PLATE (TSLP)
Applicant
Synthes Spine
1380 Enterprise Dr.
West Chester,  PA  19380
Applicant Contact VIKKI M HOFFMAN
Correspondent
Synthes Spine
1380 Enterprise Dr.
West Chester,  PA  19380
Correspondent Contact VIKKI M HOFFMAN
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received01/24/2002
Decision Date 04/22/2002
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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