OPUS TWINLOCK KNOTLESS FIXATION DEVICE

Device Classification Name

fastener, fixation, nondegradable, soft tissue

510(k) Number K071374
Device Name OPUS TWINLOCK KNOTLESS FIXATION DEVICE
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  
Subsequent Product Codes
HWC   JDR  
Date Received 05/16/2007
Decision Date 08/02/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No