DePuy ISOLA Spinal System

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

Johnson & Johnson International (Singapore) Pte Ltd

Class:

Class C medical device

Manufactured by:

DePuy Spine, Inc.

Therapeutic area:

Orthopaedics

Therapeutic indications:

Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

Product summary:

Device System Info:[System or Procedure Pack], Consists of spinal rods, eye-rods, plate-rod combinations, dual rod connectors, tandem connectors, Isola Modular Cross Conntector transverse conntors, EZ-X transverse connecotrs, CrossOver transverse connectors, spinal hooks, wires, screws.; Models: ISOLA® SPINE SYSTEM RIGHT HAND THREAD NUT 7.94mm - 203007R, ISOLA® SPINE SYSTEM WASHER, POLYAXIAL - 500064000, ISOLA® SPINE SYSTEM CLOSED HOOK 6.35 x 5mm (Stainless Steel) - 500395, ISOLA® SPINE SYSTEM - 20233630, ISOLA® SPINE SYSTEM - 20233635, ISOLA® SPINE SYSTEM - 20233640, ISOLA® SPINE SYSTEM - 20233645, ISOLA® SPINE SYSTEM - 20263630, ISOLA® SPINE SYSTEM - 20263635, ISOLA® SPINE SYSTEM - 20263640, ISOLA® SPINE SYSTEM - 20263645, ISOLA® SPINE SYSTEM - 20263650, ISOLA® SPINE SYSTEM TRANSVERSE ROD CONNECTOR 6.35mm - 203000, ISOLA® SPINE SYSTEM RIGHT HAND THREAD CLAMP JAW 6.35mm - 203001, ISOLA® SPINE SYSTEM LEFT HAND THREAD CLAMP JAW 6.35mm - 203002, ISOLA® SPINE SYSTEM UNTHREADED CLAMP JAW 6.35mm (Stainless Steel) - 203003, ISOLA® SPINE SYSTEM CLOSED BODY-NO ROD 4.75mm (Stainless Steel) - 2030050, ISOLA® SPINE SYSTEM CLOSED BODY-WITH ROD 4.75mm - 2030051, ISOLA® SPINE SYSTEM ROD WITH CENTER NUT - 203005LR, ISOLA® SPINE SYSTEM MCC SET SCREW - 203005SS, ISOLA® SPINE SYSTEM LEFT HAND THREAD NUT 7.94mm - 203006L, ISOLA® SPINE SYSTEM TRANSVERSE ROD CONNECTOR 4.75mm (Stainless Steel) - 203008, ISOLA® SPINE SYSTEM MCC HEX NUT (Stainless Steel) - 20301000, ISOLA® SPINE SYSTEM UNTHREADED CLAMP JAW 4.75mm (Stainless Steel) - 203011, ISOLA® SPINE SYSTEM SEMI OPEN DUAL CONNECTOR 6.35-6.35mm - 2030137, ISOLA® SPINE SYSTEM DUAL CONNECTOR JAW 6.35-6.35mm - 203014, ISOLA® SPINE SYSTEM CLOSED BODY-NO ROD 6.35mm (Stainless Steel) - 2030150, ISOLA® SPINE SYSTEM CLOSED BODY-WITH ROD 6.35mm (Stainless Steel) - 2030151, ISOLA® SPINE SYSTEM CLOSED EYE ROD CONNECTOR 6.35mm - 2030152, ISOLA® SPINE SYSTEM OPEN TRC SET SCREW 7.94mm - 203015SS, ISOLA® SPINE SYSTEM ASSEMBLY WITH CENTER NUT 6.35mm (Stainless Steel) - 203020, ISOLA® SPINE SYSTEM OPEN TRC BODY-NO ROD 6.35mm - 2030250, ISOLA® SPINE SYSTEM OPEN TRC BODY-WITH ROD 6.35mm - 2030251, ISOLA® SPINE SYSTEM OPEN EYE ROD CONNECTOR 6.35mm - 2030252, ISOLA® SPINE SYSTEM - 20302710, ISOLA® SPINE SYSTEM - 20302715, ISOLA® SPINE SYSTEM - 20302720, ISOLA® SPINE SYSTEM - 20302725, ISOLA® SPINE SYSTEM - 20302730, ISOLA® SPINE SYSTEM ASSEMBLY WITH CENTER NUT 4.75mm (Stainless Steel) - 203028, ISOLA® SPINE SYSTEM DUAL TRANSVERSE ASSEMBLY 4.75-4.75mm - 203032, ISOLA® SPINE SYSTEM DUAL TRANSVERSE ASSEMBLY 4.75-6.35mm - 203033, ISOLA® SPINE SYSTEM DUAL TRANSVERSE ASSEMBLY 6.35-6.35mm - 203034, ISOLA® SPINE SYSTEM CLOSED DUAL CONNECTOR 4.75-4.75mm - 203035, ISOLA® SPINE SYSTEM CLOSED DUAL CONNECTOR 4.75-4.75mm - 2030351, ISOLA® SPINE SYSTEM CLOSED DUAL CONNECTOR 4.75-6.35mm - 203036, ISOLA® SPINE SYSTEM CLOSED DUAL CONNECTOR 6.35-6.35mm - 203037, ISOLA® SPINE SYSTEM OFFSET DUAL CONNECTOR 4.75mm - 203038L, ISOLA® SPINE SYSTEM OFFSET DUAL CONNECTOR 4.75mm - 203038R, ISOLA® SPINE SYSTEM CLOSED DUAL CONNECTOR 6.35-7.0mm - 203039, ISOLA® SPINE SYSTEM OFFSET DUAL CONNECTOR 6.35mm - 203040L, ISOLA® SPINE SYSTEM OFFSET DUAL CONNECTOR 6.35mm - 203040R, ISOLA® SPINE SYSTEM - 203041, ISOLA® SPINE SYSTEM - 203043, ISOLA® SPINE SYSTEM MCC J-HOOK 4.75mm (Stainless Steel) - 2030475, ISOLA® SPINE SYSTEM MCC J-HOOK 5.0mm - 2030485, ISOLA® SPINE SYSTEM MCC PLATE 0-15mm (Stainless Steel) - 2030515, ISOLA® SPINE SYSTEM MCC PLATE 10-25mm (Stainless Steel) - 2030525, ISOLA® SPINE SYSTEM MCC PLATE 15-30mm (Stainless Steel) - 2030530, ISOLA® SPINE SYSTEM MCC PLATE 25-40mm (Stainless Steel) - 2030540, ISOLA® SPINE SYSTEM MCC PLATE 30-50mm (Stainless Steel) - 2030550, ISOLA® SPINE SYSTEM MCC PLATE 40-60mm (Stainless Steel) - 2030560, ISOLA® SPINE SYSTEM MCC PLATE 50-70mm (Stainless Steel) - 2030570, ISOLA® SPINE SYSTEM MCC J-HOOK 6.35mm (Stainless Steel) - 2030600, ISOLA® SPINE SYSTEM MCC J-HOOK 6mm - 2030635, ISOLA® SPINE SYSTEM MCC J-HOOK 7mm - 2030700, ISOLA® SPINE SYSTEM CLOSED BODY-NO ROD 4.75mm (Stainless Steel) - 2030750, ISOLA® SPINE SYSTEM CLOSED BODY-WITH ROD 4.75mm (Stainless Steel) - 2030751, ISOLA® SPINE SYSTEM ASSEMBLY WITH CENTER NUT - 203080, ISOLA® SPINE SYSTEM RIGHT HAND THREAD CLAMP JAW 6.35mm - 203081, ISOLA® SPINE SYSTEM LEFT HAND THREAD CLAMP JAW 6.35mm - 203082, ISOLA® SPINE SYSTEM UNTHREADED CLAMP JAW 6.35mm (Stainless Steel) - 203083, VSP® SPINE SYSTEM SACRAL SCREW CUT + 5 8.5 x 30mm - 22233630, VSP® SPINE SYSTEM SACRAL SCREW CUT + 5 8.5 x 35mm - 22233635, VSP® SPINE SYSTEM SACRAL SCREW CUT + 5 8.5 x 40mm - 22233640, VSP® SPINE SYSTEM SACRAL SCREW CUT + 5 8.5 x 45mm - 22233645, VSP® SPINE SYSTEM SACRAL SCREW CUT + 5 8.5 x 50mm - 22233650, ISOLA® SPINE SYSTEM TRANSVERSE ROD CONNECTOR 6.35mm - 223000, ISOLA® SPINE SYSTEM - 223001, ISOLA® SPINE SYSTEM - 223002, ISOLA® SPINE SYSTEM UNTHREADED CLAMP JAW 6.35mm (Titanium) - 223003, ISOLA® SPINE SYSTEM CLOSED BODY-NO ROD 4.75mm (Titanium) - 2230050, ISOLA® SPINE SYSTEM CLOSED BODY-WITH ROD 4.75mm (Titanium) - 2230051, ISOLA® SPINE SYSTEM MCC SET SCREW - 223005SS, ISOLA® SPINE SYSTEM RIGHT HAND THREAD NUT 7.94mm - 223007R, ISOLA® SPINE SYSTEM TRANSVERSE ROD CONNECTOR 4.75mm (Titanium) - 223008, ISOLA® SPINE SYSTEM RIGHT THREAD CLAMP JAW 4.75mm - 223009, ISOLA® SPINE SYSTEM LEFT THREAD CLAMP JAW 4.75mm - 223010, ISOLA® SPINE SYSTEM MCC HEX NUT (Titanium) - 22301000, ISOLA® SPINE SYSTEM UNTHREADED CLAMP JAW 4.75mm (Titanium) - 223011, ISOLA® SPINE SYSTEM SEMI OPEN DUAL CONNECTOR 6.35-6.35mm - 2230137, ISOLA® SPINE SYSTEM CLOSED BODY-NO ROD 6.35mm (Titanium) - 2230150, ISOLA® SPINE SYSTEM CLOSED BODY-WITH ROD 6.35mm (Titanium) - 2230151, ISOLA® SPINE SYSTEM ASSEMBLY WITH CENTER NUT 6.35mm (Titanium) - 223020, ISOLA® SPINE SYSTEM OPEN TRC BODY-NO ROD 6.35mm - 2230250, ISOLA® SPINE SYSTEM OPEN TRC BODY-WITH ROD 6.35mm - 2230251, ISOLA® SPINE SYSTEM ASSEMBLY WITH CENTER NUT 4.75mm (Titanium) - 223028, ISOLA® SPINE SYSTEM CLOSED ROD CONNECTOR 4.75-4.75mm - 223035, ISOLA® SPINE SYSTEM CLOSED ROD CONNECTOR 4.75-6.35mm - 223036, ISOLA® SPINE SYSTEM CLOSED DUAL CONNECTOR 6.35-6.35mm - 223037, ISOLA® SPINE SYSTEM - 223042, ISOLA® SPINE SYSTEM - 223044, ISOLA® SPINE SYSTEM MCC J-HOOK 4.75mm (Titanium) - 2230475, ISOLA® SPINE SYSTEM MCC J-HOOK 5.5mm - 2230495, ISOLA® SPINE SYSTEM MCC PLATE 0-15mm (Titanium) - 2230515, ISOLA® SPINE SYSTEM MCC PLATE 10-25mm (Titanium) - 2230525, ISOLA® SPINE SYSTEM MCC PLATE 15-30mm (Titanium) - 2230530, ISOLA® SPINE SYSTEM MCC PLATE 25-40mm (Titanium) - 2230540, ISOLA® SPINE SYSTEM MCC PLATE 30-50mm (Titanium) - 2230550, ISOLA® SPINE SYSTEM MCC PLATE 40-60mm (Titanium) - 2230560, ISOLA® SPINE SYSTEM MCC PLATE 50-70mm (Titanium) - 2230570, ISOLA® SPINE SYSTEM MCC J-HOOK 6.35mm (Titanium) - 2230635, ISOLA® SPINE SYSTEM - 2230636, ISOLA® SPINE SYSTEM - 30039635, VSP® SPINE SYSTEM PEDICLE SCREW NO CUT + 5 4.75 x 25mm - 30231925, VSP® SPINE SYSTEM PEDICLE SCREW NO CUT + 5 4.75 x 30mm - 30231930, VSP® SPINE SYSTEM PEDICLE SCREW NO CUT + 5 4.75 x 35mm - 30231935, VSP® SPINE SYSTEM PEDICLE SCREW NO CUT + 5 4.75 x 40mm - 30231940, VSP® SPINE SYSTEM PEDICLE SCREW NO CUT + 5 4.75 x 45mm - 30231945, VSP® SPINE SYSTEM PEDICLE SCREW NO CUT + 5 4.75 x 50mm - 30231950, VSP® SPINE SYSTEM STANDARD PEDICLE SCREW 4.75 x 25mm - 30261925, VSP® SPINE SYSTEM STANDARD PEDICLE SCREW 4.75 x 30mm - 30261930, VSP® SPINE SYSTEM STANDARD PEDICLE SCREW 4.75 x 35mm - 30261935, VSP® SPINE SYSTEM STANDARD PEDICLE SCREW 4.75 x 40mm - 30261940, VSP® SPINE SYSTEM STANDARD PEDICLE SCREW 4.75 x 45mm - 30261945, VSP® SPINE SYSTEM STANDARD PEDICLE SCREW 4.75 x 50mm - 30261950, TIMX® LOW BACK SYSTEM SACRAL SCREW NO CUT + 5 M6 8.5 x 35mm - 32233635, TIMX® LOW BACK SYSTEM SACRAL SCREW NO CUT + 5 M6 8.5 x 45mm - 32233645, ISOLA® SPINE SYSTEM PLATE/ROD COMBINATION 1 - 500001, ISOLA® SPINE SYSTEM PLATE/ROD COMBINATION 1.2 - 500001.2, ISOLA® SPINE SYSTEM PLATE/ROD COMBINATION 1.3 - 500001.3, ISOLA® SPINE SYSTEM PLATE/ROD COMBINATION 1.5 - 500001.5, ISOLA® SPINE SYSTEM CLOSED SCREW - 500001130, ISOLA® SPINE SYSTEM CLOSED SCREW - 500001135, ISOLA® SPINE SYSTEM CLOSED SCREW - 500001140, ISOLA® SPINE SYSTEM CLOSED SCREW - 5

Authorization date:

2006-03-09