MODIFICATION TO XIA SPINAL SYSTEM


Device Classification Name

orthosis, spondylolisthesis spinal fixation

510(k) Number K013688
Device Name MODIFICATION TO XIA SPINAL SYSTEM
Original Applicant
HOWMEDICA OSTEONICS CORP.
59 route 17 south
allendale, 
NJ 
07401 -1677

Original Contact karen ariemma
Regulation Number 888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   KWQ  
Date Received 11/07/2001
Decision Date 12/05/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No