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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone, Non-Spinal, Metallic
510(k) Number K021749
Device Name EBI DYNAFIX VS OSTEOTOMY SYSTEM
Applicant
EBI, L.P.
399 JEFFERSON ROAD
PARSIPPANY,  NJ  07054
Applicant Contact JON CAPARETTA
Correspondent
EBI, L.P.
399 JEFFERSON ROAD
PARSIPPANY,  NJ  07054
Correspondent Contact JON CAPARETTA
Regulation Number888.3030
Classification Product Code
NDF  
Subsequent Product Code
NDH  
Date Received05/28/2002
Decision Date 08/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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