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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 K994308
Device Name NUVASIVE TOWNLEY FACET SCREW
Applicant
Nuvasive, Inc.
10065 Old Grove Rd.
San Diego,  CA  92131
Applicant Contact STEVE REITZLER
Correspondent
Nuvasive, Inc.
10065 Old Grove Rd.
San Diego,  CA  92131
Correspondent Contact STEVE REITZLER
Classification Product Code
MRW  
Date Received12/21/1999
Decision Date 04/18/2000
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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