WRIST IMPLANT


Device Classification Name

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

510(k) Number K021859
Device Name WRIST IMPLANT
Original Applicant
AVANTA ORTHOPAEDICS, INC.
9369 carroll park drive, ste.a
san diego, 
CA 
92121

Original Contact louise m focht
Regulation Number 888.3800
Classification Product Code
JWJ  
Date Received 06/06/2002
Decision Date 12/02/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No