AESCULAP SIBD XP SPINAL SYSTEM


Device Classification Name

intervertebral fusion device with integrated fixation, lumbar

510(k) Number K111122
Device Name AESCULAP SIBD XP SPINAL SYSTEM
Applicant
AESCULAP IMPLANT SYSTEMS, INC.
3773 corporate pwky.
center valley, 
PA 
18034

Applicant Contact lisa m boyle
Correspondent
AESCULAP IMPLANT SYSTEMS, INC.
3773 corporate pwky.
center valley, 
PA 
18034

Correspodent Contact lisa m boyle
Regulation Number 888.3080
Classification Product Code
OVD  
Date Received 04/21/2011
Decision Date 08/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No