SPEEDLOCK KNOTLESS FIXATION DEVICE; 3.0MM DRILL; SHARP TIPPED OBTURATOR; LOW PROFILE DRILL GUIDDE


Device Classification Name

fastener, fixation, nondegradable, soft tissue

510(k) Number K111044
Device Name SPEEDLOCK KNOTLESS FIXATION DEVICE; 3.0MM DRILL; SHARP TIPPED OBTURATOR; LOW PROFILE DRILL GUIDDE
Applicant
ARTHROCARE CORPORATION
15285 alton parkway
suite 209
irvine, 
CA 
92618

Applicant Contact laura kasperowicz
Correspondent
ARTHROCARE CORPORATION
15285 alton parkway
suite 209
irvine, 
CA 
92618

Correspodent Contact laura kasperowicz
Regulation Number 888.3040
Classification Product Code
MBI  
Date Received 04/15/2011
Decision Date 08/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No