NEWDEAL TIBIAXYS SYSTEM


Device Classification Name

plate, fixation, bone

510(k) Number K073375
Device Name NEWDEAL TIBIAXYS SYSTEM
Applicant
NEWDEAL SAS
311 enterprise dr.
plainsboro, 
NJ 
08536

Applicant Contact judith o’grady
Correspondent
NEWDEAL SAS
311 enterprise dr.
plainsboro, 
NJ 
08536

Correspodent Contact judith o’grady
Regulation Number 888.3030
Classification Product Code
HRS  
Date Received 12/03/2007
Decision Date 02/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls