OPUS SPINAL SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K030369
Device Name OPUS SPINAL SYSTEM
Applicant
HOWMEDICA OSTEONICS CORP.
59 route 17 south
allendale, 
NJ 
07401 -1677

Applicant Contact karen ariemma
Correspondent
HOWMEDICA OSTEONICS CORP.
59 route 17 south
allendale, 
NJ 
07401 -1677

Correspodent Contact karen ariemma
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received 02/04/2003
Decision Date 08/08/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No