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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name screw, fixation, bone
510(k) Number K053394
Device Name NEXA BONE SCREW SYSTEM
Applicant
NEXA ORTHOPEDICS, INC.
10675 SORRENTO VALLEY ROAD
SUITE 100
SAN DIEGO,  CA  92121
Applicant Contact LOUISE M FOCHT
Correspondent
NEXA ORTHOPEDICS, INC.
10675 SORRENTO VALLEY ROAD
SUITE 100
SAN DIEGO,  CA  92121
Correspondent Contact LOUISE M FOCHT
Regulation Number888.3040
Classification Product Code
HWC  
Date Received12/06/2005
Decision Date 12/14/2005
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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