LANCER PEDICLE SCREW SYSTEM


Device Classification Name

orthosis, spondylolisthesis spinal fixation

510(k) Number K110633
Device Name LANCER PEDICLE SCREW SYSTEM
Applicant
SPINAL SOLUTIONS, LLC
1001 oakwood blvd
round rock, 
TX 
78681

Applicant Contact j.d. webb
Correspondent
SPINAL SOLUTIONS, LLC
1001 oakwood blvd
round rock, 
TX 
78681

Correspodent Contact j.d. webb
Regulation Number 888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received 03/04/2011
Decision Date 12/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls