C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K080646
Device Name C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM
Applicant
BIOMET SPINE
100 interpace parkway
parsippany, 
NJ 
07054

Applicant Contact jacquelyn a hughes
Correspondent
BIOMET SPINE
100 interpace parkway
parsippany, 
NJ 
07054

Correspodent Contact jacquelyn a hughes
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 03/06/2008
Decision Date 05/02/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No