VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)


Device Classification Name

staple, fixation, bone

510(k) Number K112837
Device Name VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)
Applicant
VILEX, INC.
111 moffitt street
mcminnville, 
TN 
37110

Applicant Contact sylvia southard
Correspondent
VILEX, INC.
111 moffitt street
mcminnville, 
TN 
37110

Correspodent Contact sylvia southard
Regulation Number 888.3030
Classification Product Code
JDR  
Date Received 09/28/2011
Decision Date 10/09/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No