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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, fixation, bone
510(k) Number K082807
Device Name SYNTHES (USA) 3.5 AND 4.5 MM LOCKING COMPRESSION PLATE SYSTEM WITH EXPANDED INDICATIONS
Applicant
SYNTHES (USA)
1301 GOSHEN PKWY.
west chester,  PA  19380
Applicant Contact jill r sherman
Correspondent
SYNTHES (USA)
1301 GOSHEN PKWY.
west chester,  PA  19380
Correspondent Contact jill r sherman
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received09/24/2008
Decision Date 11/24/2008
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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