ZYSTON STRAIGHT SPACER SYSTEM


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K112014
Device Name ZYSTON STRAIGHT SPACER SYSTEM
Applicant
BIOMET SPINE
100 interpace parkway
parsippany, 
NJ 
07054

Applicant Contact julie a ryan
Correspondent
BIOMET SPINE
100 interpace parkway
parsippany, 
NJ 
07054

Correspodent Contact julie a ryan
Regulation Number 888.3080
Classification Product Code
MAX  
Subsequent Product Code
MQP  
Date Received 07/14/2011
Decision Date 10/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No