DARCO HEADLESS COMPRESSION SCREW


Device Classification Name

screw, fixation, bone

510(k) Number K080850
Device Name DARCO HEADLESS COMPRESSION SCREW
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Applicant Contact theresa leister
Correspondent
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Correspodent Contact theresa leister
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 03/26/2008
Decision Date 04/10/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No