MAXFIRE MARXMEN MENISCAL REPAIR DEVICE


Device Classification Name

fastener, fixation, nondegradable, soft tissue

510(k) Number K111564
Device Name MAXFIRE MARXMEN MENISCAL REPAIR DEVICE
Applicant
BIOMET SPORTS MEDICINE
56 east bell drive
p.o. box 587
warsaw, 
IN 
46581 -0587

Applicant Contact elizabeth wray
Correspondent
BIOMET SPORTS MEDICINE
56 east bell drive
p.o. box 587
warsaw, 
IN 
46581 -0587

Correspodent Contact elizabeth wray
Regulation Number 888.3040
Classification Product Code
MBI  
Date Received 06/06/2011
Decision Date 06/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No