CAPLESS LI PEDICLE SCREW SYSTEM


Device Classification Name

orthosis, spondylolisthesis spinal fixation

510(k) Number K072282
Device Name CAPLESS LI PEDICLE SCREW SYSTEM
Applicant
X-SPINE SYSTEMS, INC.
452 alexandersville rd.
miamisburg, 
OH 
45342

Applicant Contact david kirschman
Correspondent
X-SPINE SYSTEMS, INC.
452 alexandersville rd.
miamisburg, 
OH 
45342

Correspodent Contact david kirschman
Regulation Number 888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received 08/16/2007
Decision Date 09/14/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls