ZYSTON ARC INTERBODY SPACER


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K110650
Device Name ZYSTON ARC INTERBODY SPACER
Applicant
BIOMET SPINE (AKA EBI, LLC)
100 interpace parkway
parsippany, 
NJ 
07054

Applicant Contact margaret f crowe
Correspondent
BIOMET SPINE (AKA EBI, LLC)
100 interpace parkway
parsippany, 
NJ 
07054

Correspodent Contact margaret f crowe
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 03/04/2011
Decision Date 06/30/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No