COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197


Device Classification Name

screw, fixation, bone

510(k) Number K023922
Device Name COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197
Original Applicant
COAPT SYSTEMS, INC.
1152 navarro st.
santa rosa, 
CA 
95401

Original Contact shelley trimm
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 11/25/2002
Decision Date 12/20/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No