GREAT TOE IMPLANT


Device Classification Name

prosthesis, toe, hemi-, phalangeal

510(k) Number K021063
Device Name GREAT TOE IMPLANT
Original Applicant
SIGNAL MEDICAL CORP.
3777 lapeer rd. 3-c
port huron, 
MI 
48060

Original Contact louis a serafin
Regulation Number 888.3730
Classification Product Code
KWD  
Date Received 04/02/2002
Decision Date 07/01/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No