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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K780235
Device Name ORTHOPEDIC DEVICES
Applicant
Biomet, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Biomet, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number888.3040
Classification Product Code
HWC  
Date Received02/13/1978
Decision Date 02/23/1978
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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