MODIFICATION TO SYNTHES CERVIFIX SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K030377
Device Name MODIFICATION TO SYNTHES CERVIFIX SYSTEM
Applicant
SYNTHES (USA)
1690 russell rd.
paoli, 
PA 
19301

Applicant Contact vikki m hoffman
Correspondent
SYNTHES (USA)
1690 russell rd.
paoli, 
PA 
19301

Correspodent Contact vikki m hoffman
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Code
KWP  
Date Received 02/05/2003
Decision Date 03/06/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No