ANATOMIC PEEK CERVICAL FUSION SYSTEM


Device Classification Name

intervertebral fusion device with bone graft, cervical

510(k) Number K112444
Device Name ANATOMIC PEEK CERVICAL FUSION SYSTEM
Applicant
MEDTRONIC SOFAMOR DANCK USA, INC.
1800 pyramid place
memphis, 
TN 
38132

Applicant Contact becky ronner
Correspondent
MEDTRONIC SOFAMOR DANCK USA, INC.
1800 pyramid place
memphis, 
TN 
38132

Correspodent Contact becky ronner
Regulation Number 888.3080
Classification Product Code
ODP  
Date Received 08/24/2011
Decision Date 11/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No