HELENA SYSTEM


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K110177
Device Name HELENA SYSTEM
Applicant
ROYAL OAK MEDICAL DEVICES
39533 woodward avenue
bloomfield hills, 
MI 
48304

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

Correspodent Contact matthew kroll
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 01/21/2011
Decision Date 04/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No