CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS; LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LI


Device Classification Name

prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

510(k) Number K103662
Device Name CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS; LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LI
Applicant
ZIMMER, INC.
p.o. box 708
warsaw, 
IN 
46581 -0708

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

Correspodent Contact rebecca brooks
Regulation Number 888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   LZO  
Date Received 12/15/2010
Decision Date 04/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No