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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Twister, Wire
510(k) Number K833726
Device Name KLEIN WIRE TIGHTENER/BIONIC WIRE
Applicant
Bionic Instrument Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Bionic Instrument Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number888.4540
Classification Product Code
HXS  
Date Received10/24/1983
Decision Date 12/22/1983
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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