CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE


Device Classification Name

plate, fixation, bone

510(k) Number K081374
Device Name CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Applicant Contact sarah holtgrewe
Correspondent
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Correspodent Contact sarah holtgrewe
Regulation Number 888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received 05/16/2008
Decision Date 09/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No