COMPREHENSIVE REVERSE SHOULDER


Device Classification Name

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

510(k) Number K080642
Device Name COMPREHENSIVE REVERSE SHOULDER
Applicant
BIOMET, INC.
56 east bell dr.
box 587
warsaw, 
IN 
46581 -0587

Applicant Contact patricia s beres
Correspondent
BIOMET, INC.
56 east bell dr.
box 587
warsaw, 
IN 
46581 -0587

Correspodent Contact patricia s beres
Regulation Number 888.3660
Classification Product Code
PAO  
Subsequent Product Code
KWS  
Date Received 03/06/2008
Decision Date 07/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls