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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Surgical, Fiberoptic
510(k) Number K122637
Device Name LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999
Applicant
STRYKER SPINE
2 PEARL COURT
ALLENDALE,  NJ  07401
Applicant Contact TINA MORNAK
Correspondent
STRYKER SPINE
2 PEARL COURT
ALLENDALE,  NJ  07401
Correspondent Contact TINA MORNAK
Regulation Number878.4580
Classification Product Code
FST  
Date Received08/29/2012
Decision Date 11/01/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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