STERISPINE LC CAGE


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K122021
Device Name STERISPINE LC CAGE
Applicant
SAFE ORTHOPAEDICS
parc des bellevues- allee
r luxembourg
eragny sur oise, 

FR

95610

Applicant Contact p. dumouchel
Correspondent
SAFE ORTHOPAEDICS
parc des bellevues- allee
r luxembourg
eragny sur oise, 

FR

95610

Correspodent Contact p. dumouchel
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 07/10/2012
Decision Date 09/20/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No