K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM)


Device Classification Name

prosthesis, toe, hemi-, phalangeal

510(k) Number K023770
Device Name K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM)
Original Applicant
KINETIKOS MEDICAL, INC.
4115 sorrento valley blvd.
san diego, 
CA 
92121

Original Contact john spampinato
Regulation Number 888.3730
Classification Product Code
KWD  
Date Received 11/12/2002
Decision Date 12/12/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No