5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL


Device Classification Name

fastener, fixation, nondegradable, soft tissue

510(k) Number K110164
Device Name 5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL
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 01/19/2011
Decision Date 02/07/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No