TRINICA SELECT ANTERIOR CERVICAL PLATE SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K022344
Device Name TRINICA SELECT ANTERIOR CERVICAL PLATE SYSTEM
Original Applicant
CENTERPULSE SPINE-TECH, INC.
7375 bush lake rd.
minneapolis, 
MN 
55439 -3037

Original Contact tim miller
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 07/19/2002
Decision Date 09/24/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls