NUGAIT(TM) SUBTALAR IMPLANT SYSTEM


Device Classification Name

screw, fixation, bone

510(k) Number K111799
Device Name NUGAIT(TM) SUBTALAR IMPLANT SYSTEM
Applicant
ASCENSION ORTHOPEDIC
8700 cameron rd., ste. 100
austin, 
TX 
78754

Applicant Contact bradley w strasser
Correspondent
ASCENSION ORTHOPEDIC
8700 cameron rd., ste. 100
austin, 
TX 
78754

Correspodent Contact bradley w strasser
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 06/27/2011
Decision Date 08/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No