POLARIS BE RODS

Device Classification Name

appliance, fixation, spinal interlaminal

510(k) Number K071377
Device Name POLARIS BE RODS
Applicant
BIOMET SPINE
100 interpace parkway
parsippany, 
NJ 
07054

Applicant Contact debra bing
Correspondent
BIOMET SPINE
100 interpace parkway
parsippany, 
NJ 
07054

Correspodent Contact debra bing
Regulation Number 888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI   NKB  
Date Received 05/17/2007
Decision Date 08/06/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No