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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name spinal vertebral body replacement device
510(k) Number K061578
Device Name SSP VERTEBRAL BODY REPLACEMENT
Applicant
SPECIALTY SPINE PRODUCTS, LLC
11234 EL CAMINO REAL
SUITE 200
san diego,  CA  92130
Applicant Contact floyd g larson
Correspondent
SPECIALTY SPINE PRODUCTS, LLC
11234 EL CAMINO REAL
SUITE 200
san diego,  CA  92130
Correspondent Contact floyd g larson
Regulation Number888.3060
Classification Product Code
MQP  
Date Received06/07/2006
Decision Date 12/26/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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