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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, Biodegradable, Soft Tissue
510(k) Number K001378
Device Name BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736
Applicant
BIONX IMPLANTS, INC.
HERMIANKATU 6-8 L
TAMPERE,  FI FIN-33720
Applicant Contact TUIJA ANNALA
Correspondent
BIONX IMPLANTS, INC.
HERMIANKATU 6-8 L
TAMPERE,  FI FIN-33720
Correspondent Contact TUIJA ANNALA
Regulation Number888.3030
Classification Product Code
MAI  
Date Received05/01/2000
Decision Date 07/28/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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