KNOTLESS SUTURE FIXATION SYSTEM


Device Classification Name

fastener, fixation, nondegradable, soft tissue

510(k) Number K111716
Device Name KNOTLESS SUTURE FIXATION SYSTEM
Applicant
CORE ESSENCE ORTHOPAEDICS
575a viriginia dr
ft. washington, 
PA 
19034

Applicant Contact jeff miller
Correspondent
CORE ESSENCE ORTHOPAEDICS
575a viriginia dr
ft. washington, 
PA 
19034

Correspodent Contact jeff miller
Regulation Number 888.3040
Classification Product Code
MBI  
Date Received 06/20/2011
Decision Date 11/10/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No