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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
510(k) Number K053408
Device Name NEXA BONE PLATE AND SCREW SYSTEM
Applicant
Nexa Orthopedics, Inc.
10675 Sorrento Valley Rd.
Suite 100
San Diego,  CA  92121
Applicant Contact LOUISE M FOCHT
Correspondent
Nexa Orthopedics, Inc.
10675 Sorrento Valley Rd.
Suite 100
San Diego,  CA  92121
Correspondent Contact LOUISE M FOCHT
Regulation Number888.3030
Classification Product Code
HRS  
Date Received12/07/2005
Decision Date 12/22/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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