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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name table, surgical with orthopedic accessories, manual
510(k) Number K771020
Device Name SPINAL SURGERY FRAME
Applicant
ORTHOPEDIC SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ORTHOPEDIC SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4950
Classification Product Code
JEB  
Date Received06/06/1977
Decision Date 06/17/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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