DYNA LOCKING CANNULATED SCREW


Device Classification Name

screw, fixation, bone

510(k) Number K112240
Device Name DYNA LOCKING CANNULATED SCREW
Applicant
U&I CORP.
529-1 yonghyn-dong
uijungbu, kyunggi-do, 

KR

480-050

Applicant Contact gyeong-je kwon
Correspondent
U&I CORP.
529-1 yonghyn-dong
uijungbu, kyunggi-do, 

KR

480-050

Correspodent Contact gyeong-je kwon
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 08/04/2011
Decision Date 01/04/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No