DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES

Device Classification Name

prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer

510(k) Number K071417
Device Name DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES
Applicant
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw, 
IN 
46582

Applicant Contact rhonda myer
Correspondent
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw, 
IN 
46582

Correspodent Contact rhonda myer
Regulation Number 888.3565
Classification Product Code
MBH  
Subsequent Product Code
JWH  
Date Received 05/21/2007
Decision Date 08/02/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls