AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K073470
Device Name AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX
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 888.3080
Classification Product Code
MAX  
Date Received 12/10/2007
Decision Date 03/06/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No