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Cervical Stand-alone - Fusion Implant

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Provides the benefits of an interbody spacer and an anterior cervical plate,without any of the drawbacks, designed to streamline the anterior cervical fusion procedure.

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Page 1: Cervical Stand-alone - Fusion Implant
Page 2: Cervical Stand-alone - Fusion Implant

The InterPlate™ IFD is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space.

The InterPlate™ C-P Cervical System made with PEEK OPTIMA® polymer is intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc con-firmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment.

Refer to the package insert for a complete list of warnings, precautions, indications, and contraindications.

INDICATIONS FOR USE

Part # Description Part # DescriptionRSB0712P 7mm PLATE (12mm WIDE) RSB404P SIZER 9 x 12

RSB0812P 8mm PLATE (12mm WIDE) RSB405P SIZER 10 x 12

RSB0912P 9mm PLATE (12mm WIDE) RSB407P SIZER 7 x 15

RSB1012P 10mm PLATE (12mm WIDE) RSB408P SIZER 8 x 15

RSB0715P 7mm PLATE (15mm WIDE) RSB409P SIZER 9 x 15

RSB0815P 8mm PLATE (15mm WIDE) RSB410P SIZER 10 x 15

RSB0915P 9mm PLATE (15mm WIDE) RSB411P INSERTER

RSB1015P 10mm PLATE (15mm WIDE) RSB412P CENTER PUNCH

RSB0007P 7mm COVER ASSEMBLY RSB413P BONE SCREW DRIVER

RSB0008P 8mm COVER ASSEMBLY RSB414P COVER DRIVER HANDLE

RSB0009P 9mm COVER ASSEMBLY RSB415 COVER DRIVER SHAFT

RSB0010P 10mm COVER ASSEMBLY RSB416P ROUND HOLE GUIDE TUBE

RSB3111P BONE SCREW – STANDARD RSB418 FLEX DRIVER

RSB3113P BONE SCREW – RESCUE RSB420 COVER SCREW EXTRACTOR

RSB402P SIZER 7 x 12 RSB421 BONE SCREW EXTRACTOR

RSB403P SIZER 8 x 12 RSB422P PLATE EXTRACTOR

RSB500P STERILIZATION TRAY

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INDICATIONS FOR USE

• Provides the benefits of an interbody spacer and an anterior cervical plate, without any of the drawbacks

• Combined fixation plate and spacer saves time with one step implantation

• Lower profile than anterior cervical plates and reduces gardening

• Can be implanted next to existing plates or artificial discs

• Accommodates a large amount of graft material

• Translating caudal screw and unique wedge reduce stress shielding of graft material

• Secure anti-backout screw cover accommodates variable screw angles

• Self-drilling, self-tapping screws with guide tube or freehand placement

• Multiple sizes

• Radiopaque markers

• Manufactured from PEEK-OPTIMA® polymer to facilitate fusion visualization

SIZES

13 and 15 mm inner widths17.5 and 19.5 mm overall widths7, 8, 9, 10 mm heights

The height of the ridge is matched to the length of screw travel in the slot. When the ridge is fully embedded and the screw has reached the end of the slot, the device rests on flats on the caudal surface.

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InterPlate™ C-P DimensionsImplant dimensions are shown in the following figures and Table 1.

Round Hole Sagittal: Slot Sagittal: Slot Transverse:33 º total included angle 43 º total included angle 9 º total included angle

Standard Bone Screws: 3.1mm thread diameter x 11.0mm thread lengthRescue Bone Screws: 3.1mm thread diameter x 13.0mm thread length

Table 1

CRITICAL DIMENSIONS

SCREW ROM

Dimension (mm) 7x12 8x12 9x12 10x12 7x15 8x15 9x15 10x15A) Nominal Height 7.0 8.0 9.0 10.0 7.0 8.0 9.0 10.0

B) Posterior Height 6.0 7.0 8.0 9.0 5.8 6.8 7.8 8.8

C) Overall width 17.5 17.5 17.5 17.5 19.5 19.5 19.5 19.5

D) Width 13.0 13.0 13.0 13.0 15.0 15.0 15.0 15.0

E) Depth 14.2 14.2 14.2 14.2 15.8 15.8 15.8 15.8

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