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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Facet Screw Spinal Device
510(k) Number K090767
Device Name PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER
Applicant
Interventional Spine, Inc.
13700 Alton Pkwy.
Suite 160
Irvine,  CA  92618
Applicant Contact CAROL EMERSON
Correspondent
Interventional Spine, Inc.
13700 Alton Pkwy.
Suite 160
Irvine,  CA  92618
Correspondent Contact CAROL EMERSON
Classification Product Code
MRW  
Date Received03/23/2009
Decision Date 06/11/2009
Decision SE - With Limitations (SESU)
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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