FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT


Device Classification Name

prosthesis, wrist, hemi-, ulnar

510(k) Number K112481
Device Name FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT
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 888.3810
Classification Product Code
KXE  
Date Received 08/29/2011
Decision Date 04/09/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No