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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K984200
Device Name STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE
Applicant
R. Thomas Grotz, M.D., Inc.
530 Bush St., 10th Floor
San Francisco,  CA  94108
Applicant Contact R. THOMAS GROTZ
Correspondent
R. Thomas Grotz, M.D., Inc.
530 Bush St., 10th Floor
San Francisco,  CA  94108
Correspondent Contact R. THOMAS GROTZ
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
HWC  
Date Received11/24/1998
Decision Date 01/21/1999
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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