TLS FIXATION SYSTEM


Device Classification Name

screw, fixation, bone

510(k) Number K080974
Device Name TLS FIXATION SYSTEM
Applicant
FOURNITURES HOSPITALIERES INDUSTRIE
zi de kernevez-6 rue nobel
quimper, 

FR

29000

Applicant Contact patricia donnard
Correspondent
FOURNITURES HOSPITALIERES INDUSTRIE
zi de kernevez-6 rue nobel
quimper, 

FR

29000

Correspodent Contact patricia donnard
Regulation Number 888.3040
Classification Product Code
HWC  
Subsequent Product Codes
JDR   MBI  
Date Received 04/04/2008
Decision Date 07/01/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No