PARADIGM SPINE COFLEX Interlaminar Implant

Land: Singapúr

Tungumál: enska

Heimild: HSA (Health Sciences Authority)

Fáanlegur frá:

Transmedic Pte Ltd

Tegund:

Class C medical device

Framleitt af:

PARADIGM SPINE GmbH

Lækningarsvæði:

Orthopaedics

Ábendingar:

The coflex implant is intended for permanent implantation between the spinous processes of 1 or 2 lumbar motion segments and controls segmental motion in cases of lumbar stenosis or mild degenerative instability. The coflex implant may also be used in up to 2 lumbar motion segments adjacent to fused level(s). Indications include radiographically confirmed moderate to severe stenosis, isolated to 1 or 2 levels, in the region of L1 to L5 in a patient with or without concomitant low back pain, including conditions such as stable grade 1 spondylolisthesis

Vörulýsing:

Device System Info:[System or Procedure Pack], [Sterile Medical Device], System consists of implants, trials and instruments Sterilization of implants by Gamma irradiation; Models: coflex Interlaminar implant, 8mm - UAI00008, coflex Interlaminar implant, 10mm - UAI00010, coflex Interlaminar implant, 12mm - UAI00012, coflex Interlaminar implant, 14mm - UAI00014, coflex Interlaminar implant, 16mm - UAI00016, coflex Interlaminar implant, 8mm - UBI00008, coflex Interlaminar implant, 10mm - UBI00010, coflex Interlaminar implant, 12mm - UBI00012, coflex Interlaminar implant, 14mm - UBI00014, coflex Interlaminar implant, 16mm - UBI00016, coflex Trial, 8mm - UAT00008, coflex Trial, 10mm - UAT00010, coflex Trial, 12mm - UAT00012, coflex Trial, 14mm - UAT00014, coflex Trial, 16mm - UAT00016, coflex Trial, 8mm - UAT10008, coflex Trial, 10mm - UAT10010, coflex Trial, 12mm - UAT10012, coflex Trial, 14mm - UAT10014, coflex Trial, 16mm - UAT10016, coflex Trial, 8mm - UBT10008, coflex Trial, 10mm - UBT10010, coflex Trial, 12mm - UBT10012, coflex Trial, 14mm - UBT10014, coflex Trial, 16mm - UBT10016, coflex Trial with wings, 8mm - UCT00008, coflex Trial with wings, 10mm - UCT00010, coflex Trial with wings, 12mm - UCT00012, coflex Trial with wings, 14mm - UCT00014, coflex Trial with wings, 16mm - UCT00016, coflex Trial with upper wings - UDT00007, coflex Trial with lower wings - UDT10007, coflex Trial with wings and window, 8mm - UET00008, coflex Trial with wings and window, 10mm - UET00010, coflex Trial with wings and window, 12mm - UET00012, coflex Trial with wings and window, 14mm - UET00014, coflex Trial with wings and window, 16mm - UET00016, coflex Bending pliers - UAT10100, coflex Mallet - UAT20100, coflex Mallet cap - UAT20110, coflex Crimping pliers - UAT10200, coflex Crimping pliers - UAT10220, coflex Revision pliers - UAT10300, coflex Sterilization tray - UAC00000, coflex Sterilization container - UBC00000

Leyfisdagur:

2017-09-28