SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM


Device Classification Name

appliance, fixation, spinal interlaminal

510(k) Number K112025
Device Name SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM
Applicant
SPINAL USA
2050 executive dr.
pearl, 
MS 
39208

Applicant Contact frankie cummins
Correspondent
SPINAL USA
2050 executive dr.
pearl, 
MS 
39208

Correspodent Contact frankie cummins
Regulation Number 888.3050
Classification Product Code
KWP  
Date Received 07/15/2011
Decision Date 09/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No