CLASSIC GREAT TOE IMPLANT


Device Classification Name

prosthesis, toe, constrained, polymer

510(k) Number K023086
Device Name 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 09/17/2002
Decision Date 10/04/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No