OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS FIXATION DEVICE (MODEL OM-1503)


Device Classification Name

fastener, fixation, nondegradable, soft tissue

510(k) Number K081497
Device Name OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS FIXATION DEVICE (MODEL OM-1503)
Applicant
ARTHROCARE CORP.
15285 alton parkway, #200
irvine, 
CA 
92618

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

Correspodent Contact laura n kasperowicz
Regulation Number 888.3040
Classification Product Code
MBI  
Date Received 05/29/2008
Decision Date 07/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No