FRAMEWALKER


Device Classification Name

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

510(k) Number K111993
Device Name FRAMEWALKER
Applicant
QUANTUM MEDICAL CONCEPTS, LLC.
3518 se 21st ave.
portland, 
OR 
97202

Applicant Contact alicia bach
Correspondent
QUANTUM MEDICAL CONCEPTS, LLC.
3518 se 21st ave.
portland, 
OR 
97202

Correspodent Contact alicia bach
Regulation Number 888.3030
Classification Product Code
KTT  
Date Received 07/13/2011
Decision Date 10/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No