COMPREHENSIVE RS SHOULDER SYSTEM


Device Classification Name

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

510(k) Number K072804
Device Name COMPREHENSIVE RS SHOULDER SYSTEM
Applicant
BIOMET MANUFACTURING CORP.
56 east bell drive
p.o. box 587
warsaw, 
IN 
46581 -0587

Applicant Contact patricia s beres
Correspondent
BIOMET MANUFACTURING CORP.
56 east bell drive
p.o. box 587
warsaw, 
IN 
46581 -0587

Correspodent Contact patricia s beres
Regulation Number 888.3660
Classification Product Code
KWS  
Date Received 10/01/2007
Decision Date 12/12/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No