OSTEO-CABLE SLEEVE


Device Classification Name

applier, cerclage

510(k) Number K024022
Device Name OSTEO-CABLE SLEEVE
Original Applicant
BIOMET, INC.
56 east bell dr.
warsaw, 
IN 
46581 -0587

Original Contact kacy arnold
Regulation Number 888.4540
Classification Product Code
HXN  
Subsequent Product Code
JDQ  
Date Received 12/05/2002
Decision Date 01/23/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No