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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Bone, Vertebroplasty
510(k) Number K091234
Device Name SKELTEX ISV
Applicant
Skeltex Technologies, Inc.
75 De Mortagne Blvd.
Boucherville, Quebec,  CA J4B 6Y4
Applicant Contact GEORGE PAPAGIANNIS
Correspondent
Skeltex Technologies, Inc.
75 De Mortagne Blvd.
Boucherville, Quebec,  CA J4B 6Y4
Correspondent Contact GEORGE PAPAGIANNIS
Regulation Number888.3027
Classification Product Code
NDN  
Date Received04/27/2009
Decision Date 02/16/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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