REGENEREX POROUS TITANIUM SLEEVE AUGMENTS


Device Classification Name

prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer

510(k) Number K072336
Device Name REGENEREX POROUS TITANIUM SLEEVE AUGMENTS
Applicant
BIOMET MANUFACTURING CORP.
56 east bell drive
p.o. box 587
warsaw, 
IN 
46581 -0587

Applicant Contact becky earl
Correspondent
BIOMET MANUFACTURING CORP.
56 east bell drive
p.o. box 587
warsaw, 
IN 
46581 -0587

Correspodent Contact becky earl
Regulation Number 888.3560
Classification Product Code
JWH  
Subsequent Product Codes
KRO   MBH  
Date Received 08/20/2007
Decision Date 11/05/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No