PRECIMED CANNULATED SCREW SYSTEM


Device Classification Name

screw, fixation, bone

510(k) Number K050754
Device Name PRECIMED CANNULATED SCREW SYSTEM
Applicant
PRECIMED, INC.
102 pickering way
suite 508
exton, 
PA 
19341

Applicant Contact barbara lyons
Correspondent
PRECIMED, INC.
102 pickering way
suite 508
exton, 
PA 
19341

Correspodent Contact barbara lyons
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 03/23/2005
Decision Date 05/18/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No