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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, Cervical
510(k) Number K091088
Device Name LDR SPINE CERVICAL INTERBODY FUSION SYSTEM
Applicant
Ldr Spine USA
4030 W. Braker Lane
Suite 360
Austin,  TX  78759
Applicant Contact NOAH BARTSCH
Correspondent
Ldr Spine USA
4030 W. Braker Lane
Suite 360
Austin,  TX  78759
Correspondent Contact NOAH BARTSCH
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
MQP  
Date Received04/15/2009
Decision Date 07/14/2009
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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