5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAP


Device Classification Name

fastener, fixation, nondegradable, soft tissue

510(k) Number K110781
Device Name 5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAP
Applicant
ARTHROCARE CORP.
680 vaqueros ave.
sunnyvale, 
CA 
94085 -3523

Applicant Contact valerie defiesta-ng
Correspondent
ARTHROCARE CORP.
680 vaqueros ave.
sunnyvale, 
CA 
94085 -3523

Correspodent Contact valerie defiesta-ng
Regulation Number 888.3040
Classification Product Code
MBI  
Date Received 03/21/2011
Decision Date 05/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No