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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 K972326
Device Name PEBA ANCHOR/SUTURE COMBINATION
Applicant
Orthopaedic Biosystems, Ltd.
7320 E. Butherus
Suite 206
Scotsdale,  AZ  85260
Applicant Contact JEFFREY B SKIBA
Correspondent
Orthopaedic Biosystems, Ltd.
7320 E. Butherus
Suite 206
Scotsdale,  AZ  85260
Correspondent Contact JEFFREY B SKIBA
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
JDR  
Date Received06/23/1997
Decision Date 02/06/1998
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
Recalls CDRH Recalls
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