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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K071637
Device Name INTRINSIC THERAPEUTICS FIXATION STAPLE
Applicant
Intrinsic Therapeutics Incorporated
30 Commerce Way
Woburn,  MA  01801
Applicant Contact KRISHNA UPPUGONDURI
Correspondent
Intrinsic Therapeutics Incorporated
30 Commerce Way
Woburn,  MA  01801
Correspondent Contact KRISHNA UPPUGONDURI
Regulation Number888.3030
Classification Product Code
JDR  
Date Received06/15/2007
Decision Date 08/03/2007
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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