AMATOMICAL SHOULDER WITH REMOVABLE HEAD


Device Classification Name

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

510(k) Number K030259
Device Name AMATOMICAL SHOULDER WITH REMOVABLE HEAD
Original Applicant
CENTERPLUS ORTHOPEDICS, INC
9900 spectrum dr.
austin, 
TX 
78717

Original Contact audrey swearingen
Regulation Number 888.3660
Classification Product Code
KWS  
Subsequent Product Code
HSD  
Date Received 01/24/2003
Decision Date 04/24/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls