OSTEOMED CRANIAL FLAP FIXATION SYSTEM


Device Classification Name

plate, cranioplasty, preformed, non-alterable

510(k) Number K022277
Device Name OSTEOMED CRANIAL FLAP FIXATION SYSTEM
Original Applicant
OSTEOMED CORP.
3750 realty rd.
addison, 
TX 
75001 -4311

Original Contact dawn t holdeman
Regulation Number 882.5330
Classification Product Code
GXN  
Date Received 07/15/2002
Decision Date 04/01/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No