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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K130057
Device Name ESPIN
Applicant
Nlt Spine, Ltd.
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact JOHN J SMITH
Correspondent
Nlt Spine, Ltd.
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact JOHN J SMITH
Regulation Number888.1100
Classification Product Code
HRX  
Date Received01/09/2013
Decision Date 02/07/2013
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
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