1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM


Device Classification Name

screw, fixation, bone

510(k) Number K023260
Device Name 1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM
Original Applicant
OSTEOMED CORP.
3750 realty rd.
addison, 
TX 
75001 -4311

Original Contact dawn t holdeman
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 09/30/2002
Decision Date 10/18/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No