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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue
510(k) Number K993061
Device Name STRYKER LEIBINGER RESORBABLE FIXATION SYSTEM
Applicant
Stryker Instruments
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Applicant Contact KRISTEN R KELLEY
Correspondent
Stryker Instruments
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Correspondent Contact KRISTEN R KELLEY
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Codes
HRS   HWC  
Date Received09/13/1999
Decision Date 11/19/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
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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