ASCENSION PYROCARBON LUNATE


Device Classification Name

prosthesis, wrist, carpal lunate

510(k) Number K080997
Device Name ASCENSION PYROCARBON LUNATE
Applicant
ASCENSION ORTHOPEDICS, INC.
8700 cameron rd., ste. 100
austin, 
TX 
78754 -3832

Applicant Contact debbie stearns
Correspondent
ASCENSION ORTHOPEDICS, INC.
8700 cameron rd., ste. 100
austin, 
TX 
78754 -3832

Correspodent Contact debbie stearns
Regulation Number 888.3750
Classification Product Code
KWN  
Date Received 04/08/2008
Decision Date 06/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No