TETRIS SPINAL IMPLANT


Device Classification Name

spinal vertebral body replacement device

510(k) Number K022793
Device Name TETRIS SPINAL IMPLANT
Original Applicant
SIGNUS MEDICAL LLC.
4050 olson memorial highway
suite 350
minneapolis, 
MN 
55422

Original Contact ann quinlan-smith
Regulation Number 888.3060
Classification Product Code
MQP  
Date Received 08/23/2002
Decision Date 04/08/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No