WMT ULTRA-FIT MODULAR SHOULDER SYSTEM


information about

Device Classification Name

prosthesis, shoulder, semi-constrained, metal/polymer cemented

510(k) Number K002683
Device Name WMT ULTRA-FIT MODULAR SHOULDER SYSTEM
Original Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline rd.
arlington, 
TN 
38002

Original Contact ehab m esmail
Regulation Number 888.3660
Classification Product Code
KWS  
Subsequent Product Code
HSD  
Date Received 08/28/2000
Decision Date 11/22/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No