S4 SPINAL SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K050979
Device Name S4 SPINAL SYSTEM
Applicant
AESCULAP, INC.
3773 corporate parkway
center valley, 
PA 
18034

Applicant Contact joyce kilroy
Correspondent
AESCULAP, INC.
3773 corporate parkway
center valley, 
PA 
18034

Correspodent Contact joyce kilroy
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Code
KWP  
Date Received 04/19/2005
Decision Date 07/27/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No