ARROW-LOK DIGITAL SYSTEM


Device Classification Name

pin, fixation, smooth

510(k) Number K112675
Device Name ARROW-LOK DIGITAL SYSTEM
Applicant
ARROWHEAD MEDICAL DEVICE TECHNOLOGIES LLC
328 poplar view lane east
suite 2
collierville, 
TN 
38017

Applicant Contact thomas j twardzik
Correspondent
ARROWHEAD MEDICAL DEVICE TECHNOLOGIES LLC
328 poplar view lane east
suite 2
collierville, 
TN 
38017

Correspodent Contact thomas j twardzik
Regulation Number 888.3040
Classification Product Code
HTY  
Date Received 09/14/2011
Decision Date 12/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No