OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM


Device Classification Name

plate, cranioplasty, preformed, alterable

510(k) Number K111176
Device Name OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM
Applicant
OSTEOMED L.P.
3885 arapaho rd.
addison, 
TX 
75001

Applicant Contact piedad pena
Correspondent
OSTEOMED L.P.
3885 arapaho rd.
addison, 
TX 
75001

Correspodent Contact piedad pena
Regulation Number 882.5320
Classification Product Code
GWO  
Subsequent Product Code
GXR  
Date Received 04/27/2011
Decision Date 08/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No