MODIFICATION TO OASYS SYSTEM


Device Classification Name

appliance, fixation, spinal interlaminal

510(k) Number K072568
Device Name MODIFICATION TO OASYS SYSTEM
Applicant
STRYKER SPINE
2 pearl court
allendale, 
NJ 
07401

Applicant Contact simona voic
Correspondent
STRYKER SPINE
2 pearl court
allendale, 
NJ 
07401

Correspodent Contact simona voic
Regulation Number 888.3050
Classification Product Code
KWP  
Subsequent Product Code
MNI  
Date Received 09/12/2007
Decision Date 10/05/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No