OASYS SPINAL SYSTEM


Device Classification Name

appliance, fixation, spinal interlaminal

510(k) Number K111719
Device Name OASYS SPINAL SYSTEM
Applicant
STRYKER SPINE
2 pearl court
allendale, 
NJ 
07401

Applicant Contact soraya king
Correspondent
STRYKER SPINE
2 pearl court
allendale, 
NJ 
07401

Correspodent Contact soraya king
Regulation Number 888.3050
Classification Product Code
KWP  
Date Received 06/20/2011
Decision Date 01/19/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No