AVS PL PEEK SPACERS, MODELS 48351 AND 48353


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K080758
Device Name AVS PL PEEK SPACERS, MODELS 48351 AND 48353
Applicant
STRYKER CORP.
2 pearl court
allendale, 
NJ 
07401

Applicant Contact vikki m o’connor
Correspondent
STRYKER CORP.
2 pearl court
allendale, 
NJ 
07401

Correspodent Contact vikki m o’connor
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 03/18/2008
Decision Date 03/27/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No