GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN..


Device Classification Name

fastener, fixation, nondegradable, soft tissue

510(k) Number K111631
Device Name GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN..
Applicant
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
325 paramount dr.
raynham, 
MA 
02767

Applicant Contact deep pal
Correspondent
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
325 paramount dr.
raynham, 
MA 
02767

Correspodent Contact deep pal
Regulation Number 888.3040
Classification Product Code
MBI  
Date Received 06/13/2011
Decision Date 07/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No