JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE


Device Classification Name

appliance, fixation, nail/blade/plate combination, multiple component

510(k) Number K072212
Device Name JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE
Applicant
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis, 
TN 
38116

Applicant Contact david henley
Correspondent
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis, 
TN 
38116

Correspodent Contact david henley
Regulation Number 888.3030
Classification Product Code
KTT  
Date Received 08/09/2007
Decision Date 03/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No