ATHENA PEDICLE SCREW SYSTEM


Device Classification Name

orthosis, spinal pedicle fixation, for degenerative disc disease

510(k) Number K110046
Device Name ATHENA PEDICLE SCREW SYSTEM
Applicant
ROYAL OAK MEDICAL DEVICES
39533 woodward avenue
bloomfield hills, 
MI 
48304

Applicant Contact mathew kroll
Correspondent
ROYAL OAK MEDICAL DEVICES
39533 woodward avenue
bloomfield hills, 
MI 
48304

Correspodent Contact mathew kroll
Regulation Number 888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received 01/06/2011
Decision Date 12/07/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No