BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS


Device Classification Name

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

510(k) Number K073102
Device Name BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS
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 888.3353
Classification Product Code
LZO  
Subsequent Product Codes
JDI   LPH   LWJ   MAY   OQG  
OQH   OQI  
Date Received 11/02/2007
Decision Date 11/27/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No