ENDIUS TITLE SPINAL FIXATION SYSTEM


Device Classification Name

orthosis, spondylolisthesis spinal fixation

510(k) Number K021881
Device Name ENDIUS TITLE SPINAL FIXATION SYSTEM
Original Applicant
ENDIUS, INC.
23 west bacon st.
plainville, 
MA 
02762

Original Contact christine kuntz-nassif
Regulation Number 888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   MNI  
Date Received 06/07/2002
Decision Date 07/29/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No