TRI-FIX SPINAL FIXATION SYSTEM


information about

Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K000766
Device Name TRI-FIX SPINAL FIXATION SYSTEM
Original Applicant
ENDIUS, INC.
23 west bacon st.
plainville, 
MA 
02762

Original Contact susan finneran
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received 03/09/2000
Decision Date 06/01/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Traditional
Reviewed by Third Party No

Combination Product

No