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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Interlaminal
510(k) Number K930009
Device Name STRYKER 2S SPINAL SYSTEM
Applicant
Stryker Corp.
2 Pease Ct.
59 Route 17,  NJ  07401
Applicant Contact BOB KOCH
Correspondent
Stryker Corp.
2 Pease Ct.
59 Route 17,  NJ  07401
Correspondent Contact BOB KOCH
Regulation Number888.3050
Classification Product Code
KWP  
Date Received01/04/1993
Decision Date 09/01/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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