MODIFICATION TO CLASSIC GREAT TOE IMPLANT


Device Classification Name

prosthesis, toe, constrained, polymer

510(k) Number K023562
Device Name MODIFICATION TO CLASSIC GREAT TOE IMPLANT
Original Applicant
NEXA ORTHOPEDICS, INC.
990 park center dr., suite h
vista, 
CA 
92083

Original Contact louise m focht
Regulation Number 888.3720
Classification Product Code
KWH  
Date Received 10/23/2002
Decision Date 11/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No