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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K925328
Device Name ANSPACH BONE RIVET, ANSPACH SUTURE ANCHOR
Applicant
Anspach Mfg., Inc.
1349 S. Killian Dr.
Lake Park,  FL  33403
Applicant Contact WILLIAM E ANSPACH
Correspondent
Anspach Mfg., Inc.
1349 S. Killian Dr.
Lake Park,  FL  33403
Correspondent Contact WILLIAM E ANSPACH
Regulation Number888.3040
Classification Product Code
HWC  
Date Received10/21/1992
Decision Date 10/27/1993
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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