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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 K801080
Device Name EDWARDS ROD SLEEVES
Applicant
Zimmer, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Zimmer, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number888.3050
Classification Product Code
KWP  
Date Received05/07/1980
Decision Date 05/20/1980
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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