ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD


Device Classification Name

prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

510(k) Number K111936
Device Name ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD
Applicant
ORTHO DEVELOPMENT
12187 s. business park dr.
draper, 
UT 
84020

Applicant Contact tom haueter
Correspondent
ORTHO DEVELOPMENT
12187 s. business park dr.
draper, 
UT 
84020

Correspodent Contact tom haueter
Regulation Number 888.3353
Classification Product Code
LZO  
Date Received 07/08/2011
Decision Date 09/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No