ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K081038
Device Name ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
Applicant
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis, 
TN 
38132

Applicant Contact chris mckee
Correspondent
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis, 
TN 
38132

Correspodent Contact chris mckee
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 04/11/2008
Decision Date 08/15/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls