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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 K001323
Device Name NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW
Applicant
Nuvasive, Inc.
10065 Old Grove Rd.
San Diego,  CA  92131
Applicant Contact LAETITIA BERNARD
Correspondent
Nuvasive, Inc.
10065 Old Grove Rd.
San Diego,  CA  92131
Correspondent Contact LAETITIA BERNARD
Classification Product Code
MRW  
Date Received04/26/2000
Decision Date 07/25/2000
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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