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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 K884688
Device Name MODULAR SPINAL FIXATION & LOCKING HOOK SPINAL ROD
Applicant
Synthes (Usa)
1690 Russell Rd.
Post Office Box 1766
Paoli,  PA  19301
Applicant Contact MICHAEL C SHERMAN
Correspondent
Synthes (Usa)
1690 Russell Rd.
Post Office Box 1766
Paoli,  PA  19301
Correspondent Contact MICHAEL C SHERMAN
Regulation Number888.3050
Classification Product Code
KWP  
Date Received11/08/1988
Decision Date 02/24/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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