SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75


Device Classification Name

fastener, fixation, nondegradable, soft tissue

510(k) Number K111399
Device Name SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75
Applicant
ARTHROCARE CORP.
15285 alton parkway
suite 200
irvine, 
CA 
92618

Applicant Contact laura kasperowicz
Correspondent
ARTHROCARE CORP.
15285 alton parkway
suite 200
irvine, 
CA 
92618

Correspodent Contact laura kasperowicz
Regulation Number 888.3040
Classification Product Code
MBI  
Date Received 05/19/2011
Decision Date 07/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No