TAPERLOC COMPLETE MICROPLASTY STEM


Device Classification Name

prosthesis, hip, semi-constrained (metal uncemented acetabular component)

510(k) Number K110400
Device Name TAPERLOC COMPLETE MICROPLASTY STEM
Applicant
BIOMET MANUFACTURING CORP.
po box 587
warsaw, 
IN 
46581 -0587

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

Correspodent Contact becky earl
Regulation Number 888.3330
Classification Product Code
KWA  
Subsequent Product Codes
JDI   JDL   KWL   KWY   KWZ  
LPH   LZO   MEH   OQG  
Date Received 02/11/2011
Decision Date 09/30/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No