SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K022791
Device Name SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM
Original Applicant
SYNTHES (USA)
1690 russell rd.
paoli, 
PA 
19301

Original Contact vikki m hoffman
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 08/22/2002
Decision Date 11/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No