BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION


Device Classification Name

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

510(k) Number K110791
Device Name BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION
Applicant
ZIMMER, INC.
p.o. box 708
warsaw, 
IN 
46581 -0708

Applicant Contact anthony francalancia
Correspondent
ZIMMER, INC.
p.o. box 708
warsaw, 
IN 
46581 -0708

Correspodent Contact anthony francalancia
Regulation Number 888.3650
Classification Product Code
KWT  
Subsequent Product Code
HSD  
Date Received 03/21/2011
Decision Date 09/02/2011
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