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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 K082795
Device Name SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT
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 Received09/23/2008
Decision Date 12/12/2008
Decision Substantially Equivalent (SESE)
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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