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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 K994383
Device Name DOGBONE ACFS
Applicant
Theken Surgical
1100 Nola Ave.
Barberton,  OH  44203
Applicant Contact LUKAS EISERMANN
Correspondent
Theken Surgical
1100 Nola Ave.
Barberton,  OH  44203
Correspondent Contact LUKAS EISERMANN
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received12/28/1999
Decision Date 02/04/2000
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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