ALTUM ANTERIOR CERVICAL PLATE


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K103505
Device Name ALTUM ANTERIOR CERVICAL PLATE
Applicant
SPINECRAFT LLC
2215 enterprise drive
suite 1504
westchester, 
IL 
60154

Applicant Contact ami akallal-asaad
Correspondent
SPINECRAFT LLC
2215 enterprise drive
suite 1504
westchester, 
IL 
60154

Correspodent Contact ami akallal-asaad
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 11/29/2010
Decision Date 03/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No