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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar
510(k) Number K130506
Device Name IMSE P-TLIF
Applicant
Institute of Musculoskeletal Science & Education
90 S. Newtown St. Rd.
Suite 10
Newtown Square,  PA  19073
Applicant Contact JOHN MORAN
Correspondent
Institute of Musculoskeletal Science & Education
90 S. Newtown St. Rd.
Suite 10
Newtown Square,  PA  19073
Correspondent Contact JOHN MORAN
Regulation Number888.3080
Classification Product Code
MAX  
Date Received02/27/2013
Decision Date 05/13/2013
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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