BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS


Device Classification Name

screw, fixation, bone

510(k) Number K080088
Device Name BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS
Applicant
BIOMET MANUFACTURING, INC.
56 east bell dr.
warsaw, 
IN 
46581 -0587

Applicant Contact robert r friddle
Correspondent
BIOMET MANUFACTURING, INC.
56 east bell dr.
warsaw, 
IN 
46581 -0587

Correspodent Contact robert r friddle
Regulation Number 888.3040
Classification Product Code
HWC  
Subsequent Product Codes
JDR   MAI   MBI  
Date Received 01/14/2008
Decision Date 06/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls