THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE)


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K072231
Device Name THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE)
Applicant
ESM TECHNOLOGIES, LLC.
403 farwell dr.
madison, 
WI 
53704

Applicant Contact cliff tribus
Correspondent
ESM TECHNOLOGIES, LLC.
403 farwell dr.
madison, 
WI 
53704

Correspodent Contact cliff tribus
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 08/10/2007
Decision Date 12/26/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No