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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 K080649
Device Name POGO SCREW
Applicant
Fxdevices
One S. Ocean Blvd.
Boca Raton,  FL  33432
Applicant Contact RICH LIPSCHUTZ
Correspondent
Fxdevices
One S. Ocean Blvd.
Boca Raton,  FL  33432
Correspondent Contact RICH LIPSCHUTZ
Regulation Number888.3040
Classification Product Code
HWC  
Date Received03/07/2008
Decision Date 11/25/2008
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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