C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE


Device Classification Name

intervertebral fusion device with bone graft, cervical

510(k) Number K121320
Device Name C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE
Applicant
MEDYSSEY CO., LTD.
8001 n. lincoln ave
suite 401
skokie, 
IL 
60077

Applicant Contact michael kvitnitsky
Correspondent
MEDYSSEY CO., LTD.
8001 n. lincoln ave
suite 401
skokie, 
IL 
60077

Correspodent Contact michael kvitnitsky
Regulation Number 888.3080
Classification Product Code
ODP  
Date Received 05/02/2012
Decision Date 08/10/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No