DYNA-EXTOR II


Device Classification Name

appliance, fixation, nail/blade/plate combination, multiple component

510(k) Number K110426
Device Name DYNA-EXTOR II
Applicant
BK MEDITECH CO., LTD.
po box 560
stillwater, 
MN 
55082

Applicant Contact elaine duncan
Correspondent
BK MEDITECH CO., LTD.
po box 560
stillwater, 
MN 
55082

Correspodent Contact elaine duncan
Regulation Number 888.3030
Classification Product Code
KTT  
Date Received 02/14/2011
Decision Date 11/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No