STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT


Device Classification Name

prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

510(k) Number K080979
Device Name STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT
Applicant
BIOMET MANUFACTURING CORP.
po box 587
warsaw, 
IN 
46581 -0587

Applicant Contact gary baker
Correspondent
BIOMET MANUFACTURING CORP.
po box 587
warsaw, 
IN 
46581 -0587

Correspodent Contact gary baker
Regulation Number 888.3390
Classification Product Code
KWY  
Subsequent Product Code
KWL  
Date Received 04/07/2008
Decision Date 10/31/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes