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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Component, Traction, Invasive
510(k) Number K920149
Device Name OSTEO EX-FI-RE
Applicant
Osteo AG
208 Wilson Bridge Rd.
Greenwood,  SC  29646
Applicant Contact BRYSON, JR.
Correspondent
Osteo AG
208 Wilson Bridge Rd.
Greenwood,  SC  29646
Correspondent Contact BRYSON, JR.
Regulation Number888.3040
Classification Product Code
JEC  
Date Received01/10/1992
Decision Date 04/09/1992
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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