PEEK PREVAIL CERVICAL INTERBODY DEVICE


Device Classification Name

intervertebral fusion device with bone graft, cervical

510(k) Number K073285
Device Name PEEK PREVAIL CERVICAL INTERBODY DEVICE
Applicant
MEDTRONIC SOFAMOR DANEK USA, INC.
1800 pyramid place
memphis, 
TN 
38132

Applicant Contact michael scott
Correspondent
MEDTRONIC SOFAMOR DANEK USA, INC.
1800 pyramid place
memphis, 
TN 
38132

Correspodent Contact michael scott
Regulation Number 888.3080
Classification Product Code
ODP  
Date Received 11/23/2007
Decision Date 05/15/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No