MODIFICATION TO RADIAL HEAD IMPLANT


Device Classification Name

prosthesis, elbow, hemi-, radial, polymer

510(k) Number K023604
Device Name MODIFICATION TO RADIAL HEAD IMPLANT
Original Applicant
AVANTA ORTHOPAEDICS, INC.
9369 carroll park drive, ste.a
san diego, 
CA 
92121

Original Contact louise focht
Regulation Number 888.3170
Classification Product Code
KWI  
Date Received 10/28/2002
Decision Date 11/27/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No