Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL BIT) 1.8MM


Device Classification Name

fastener, fixation, nondegradable, soft tissue

510(k) Number K122336
Device Name Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL BIT) 1.8MM
Applicant
ELEVEN BLADE SOLUTIONS, INC.
14734 la rinconada drive
los gatos, 
CA 
95032

Applicant Contact michael kolber
Correspondent
ELEVEN BLADE SOLUTIONS, INC.
14734 la rinconada drive
los gatos, 
CA 
95032

Correspodent Contact michael kolber
Regulation Number 888.3040
Classification Product Code
MBI  
Date Received 08/02/2012
Decision Date 01/09/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No