Valsts: Singapūra
Valoda: angļu
Klimata pārmaiņas: HSA (Health Sciences Authority)
SMITH & NEPHEW PTE. LIMITED
Class C medical device
ArthroCare Corporation
Orthopaedics
The SpeedLock Knotless Fixation Device is an implant that facilitates the attachment of tissue to bone. The SpeedLock system consists of a fixation device pre-loaded with a suture snare in an inserter handle. The SpeedLock implant is a knotless fixation device, in other words surgical knots are not necessary for fixation of suture to tissue. The SpeedLock Knotless Fixation Device is indicated for use in the fixation of soft tissue to bone. Examples of procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair; Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction; Foot: Hallux valgus reconstruction; Elbow: Tennis elbow repair, biceps tendon reattachment; Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; capsular reconst, ITB tenodesis; patellar ligament and tendon avulsions
Device System Info:[System or Procedure Pack], [Sterile Medical Device], System comprising fixation device, suture and associated instruments. Implantable devices are sterilized via Ethylene Oxide (EO).; Models: SpeedLock PEEK 3.4mm Knotless Fixation Device - OM-7500, SpeedLock® High Visibility Drill Guide - OM-9715, 3.5mm Drill Guide - OM-9716, Sharp Tipped Obturator - OM-9717, 3.0mm Tapered Twist Drill - OM-9750, LabraLock P Pathfinder - OM-9316, MagnumWire® Nonabsorbable Suture (White) - OM-9041, MagnumWire® Nonabsorbable Suture w/Needle (White) - OM-9053
2014-07-21