5.5 MM SUTURE LOCK BONE SCREW ANCHOR


Device Classification Name

fastener, fixation, nondegradable, soft tissue

510(k) Number K080229
Device Name 5.5 MM SUTURE LOCK BONE SCREW ANCHOR
Applicant
KFX MEDICAL
5845 avenida encinas,suite 130
carlsbad, 
CA 
92008

Applicant Contact gayle hirota
Correspondent
KFX MEDICAL
5845 avenida encinas,suite 130
carlsbad, 
CA 
92008

Correspodent Contact gayle hirota
Regulation Number 888.3040
Classification Product Code
MBI  
Subsequent Product Code
HWC  
Date Received 01/30/2008
Decision Date 02/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No