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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 K951451
Device Name PEBA ANCHOR (MULTIPLE SIZES)
Applicant
Orthopaedic Biosystems, Ltd.
7320 E. Butherus
Suite 206
Scotsdale,  AZ  85260
Applicant Contact DTHOMAS M MCINTOSH
Correspondent
Orthopaedic Biosystems, Ltd.
7320 E. Butherus
Suite 206
Scotsdale,  AZ  85260
Correspondent Contact DTHOMAS M MCINTOSH
Regulation Number888.3040
Classification Product Code
MBI  
Date Received03/29/1995
Decision Date 10/31/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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