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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 K053136
Device Name 5TH METATARSAL FRACTURE SCREW
Applicant
Wrightmedicaltechnologyinc
5677 Airline Rd.
Arlington,  TN  38002
Applicant Contact WESLEY L REED
Correspondent
Wrightmedicaltechnologyinc
5677 Airline Rd.
Arlington,  TN  38002
Correspondent Contact WESLEY L REED
Regulation Number888.3040
Classification Product Code
HWC  
Date Received11/09/2005
Decision Date 01/05/2006
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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