STABILIZATION SCREW


Device Classification Name

screw, fixation, bone

510(k) Number K050346
Device Name STABILIZATION SCREW
Applicant
NEWDEAL S.A.
311 enterprise drive
plainsboro, 
NJ 
08536

Applicant Contact judith e o’grady
Correspondent
NEWDEAL S.A.
311 enterprise drive
plainsboro, 
NJ 
08536

Correspodent Contact judith e o’grady
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 02/11/2005
Decision Date 03/17/2005
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