BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM


Device Classification Name

prosthesis, hip, semi-constrained, metal/polymer, cemented

510(k) Number K992058
Device Name BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM
Applicant
BIOMET, INC.
airport industrial park,
p.o.box 587
warsaw, 
IN 
46581 -0587

Applicant Contact mary l verstynen
Correspondent
BIOMET, INC.
airport industrial park,
p.o.box 587
warsaw, 
IN 
46581 -0587

Correspodent Contact mary l verstynen
Regulation Number 888.3350
Classification Product Code
JDI  
Date Received 06/18/1999
Decision Date 07/01/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No