TRAUSON INTRAMEDULLARY NAIL


Device Classification Name

rod, fixation, intramedullary and accessories

510(k) Number K081230
Device Name TRAUSON INTRAMEDULLARY NAIL
Applicant
TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD.
lane 999, zhongshan no. 2 road
suite 8d, no. 19
shanghai, 

CN

200030

Applicant Contact diana hong
Correspondent
TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD.
lane 999, zhongshan no. 2 road
suite 8d, no. 19
shanghai, 

CN

200030

Correspodent Contact diana hong
Regulation Number 888.3020
Classification Product Code
HSB  
Date Received 04/30/2008
Decision Date 01/13/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No