ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS


Device Classification Name

prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

510(k) Number K112556
Device Name ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS
Applicant
HOWMEDICA OSTEONICS CORP
325 corporate dr.
mahwah, 
NJ 
07430

Applicant Contact valerie giambanco
Correspondent
HOWMEDICA OSTEONICS CORP
325 corporate dr.
mahwah, 
NJ 
07430

Correspodent Contact valerie giambanco
Regulation Number 888.3353
Classification Product Code
MEH  
Subsequent Product Code
LZO  
Date Received 09/02/2011
Decision Date 09/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls