UNIVERSAL TOTAL WRIST SYSTEM


Device Classification Name

prosthesis, wrist, 3 part metal-plastic-metal articulation, semi-constrained

510(k) Number K030037
Device Name UNIVERSAL TOTAL WRIST SYSTEM
Original Applicant
KINETIKOS MEDICAL, INC.
6005 hidden valley rd, ste 180
carlsbad, 
CA 
92011

Original Contact john spampinato
Regulation Number 888.3800
Classification Product Code
JWJ  
Date Received 01/06/2003
Decision Date 02/05/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No