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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K092624
Device Name FIREBIRD SPINAL FIXATION SYSTEM
Applicant
Blackstone Medical, Inc.
1211 Hamburg Turnpike,
Suite 300
Wayne,  NJ  07470
Applicant Contact WHITNEY G TORNING
Correspondent
Blackstone Medical, Inc.
1211 Hamburg Turnpike,
Suite 300
Wayne,  NJ  07470
Correspondent Contact WHITNEY G TORNING
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received08/26/2009
Decision Date 09/25/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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