Xpress Minimally Invasive Pedicle Screw System

GUDID M697X0737575DL1

XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 75mm

Xtant Medical Holdings, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: M697X0737575DL1
• NIH Device Record Key: d503fee4-eda5-4591-995f-3e5c865ed4a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xpress Minimally Invasive Pedicle Screw System
• Version Model Number: X073-7575-DL
• Company DUNS: 081224143
• Company Name: Xtant Medical Holdings, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(937)847-8400
• Email: orders@x-spine.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com
• Phone: +1(888)886-9354
• Email: cs@xtantmedical.com

Device Dimensions

• Outer Diameter: 7.5 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 75 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M697X0737575DL1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152132

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[M697X0737575DL1]

Moist Heat or Steam Sterilization

[M697X0737575DL1]

Moist Heat or Steam Sterilization

[M697X0737575DL1]

Moist Heat or Steam Sterilization

[M697X0737575DL1]

Moist Heat or Steam Sterilization

[M697X0737575DL1]

Moist Heat or Steam Sterilization

[M697X0737575DL1]

Moist Heat or Steam Sterilization

[M697X0737575DL1]

Moist Heat or Steam Sterilization

[M697X0737575DL1]

Moist Heat or Steam Sterilization

[M697X0737575DL1]

Moist Heat or Steam Sterilization

[M697X0737575DL1]

Moist Heat or Steam Sterilization

[M697X0737575DL1]

Moist Heat or Steam Sterilization

[M697X0737575DL1]

Moist Heat or Steam Sterilization

[M697X0737575DL1]

Moist Heat or Steam Sterilization

[M697X0737575DL1]

Moist Heat or Steam Sterilization

[M697X0737575DL1]

Moist Heat or Steam Sterilization

[M697X0737575DL1]

Moist Heat or Steam Sterilization

[M697X0737575DL1]

Moist Heat or Steam Sterilization

[M697X0737575DL1]

Moist Heat or Steam Sterilization

[M697X0737575DL1]

Moist Heat or Steam Sterilization

[M697X0737575DL1]

Moist Heat or Steam Sterilization

[M697X0737575DL1]

Moist Heat or Steam Sterilization

[M697X0737575DL1]

Moist Heat or Steam Sterilization

[M697X0737575DL1]

Moist Heat or Steam Sterilization

[M697X0737575DL1]

Moist Heat or Steam Sterilization

[M697X0737575DL1]

Moist Heat or Steam Sterilization

[M697X0737575DL1]

Moist Heat or Steam Sterilization

[M697X0737575DL1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-06-03
• Device Publish Date: 2016-02-23

On-Brand Devices [Xpress Minimally Invasive Pedicle Screw System]

• M697X073825951: XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 95mm
• M697X073825901: XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 90mm
• M697X073825851: XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 85mm
• M697X073825801: XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 80mm
• M697X073825751: XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 75mm
• M697X073825701: XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 70mm
• M697X073825651: XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 65mm
• M697X073825601: XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 60mm
• M697X07382555DL1: XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 8.25 x 55mm
• M697X073825551: XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 55mm
• M697X07382550DL1: XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 8.25 x 50mm
• M697X073825501: XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 50mm
• M697X07382545DL1: XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 8.25 x 45mm
• M697X073825451: XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 45mm
• M697X07382540DL1: XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 8.25 x 40mm
• M697X073825401: XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 40mm
• M697X07382535DL1: XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 8.25 x 35mm
• M697X073825351: XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 35mm
• M697X07382530DL1: XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 8.25 x 30mm
• M697X073825301: XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 30mm
• M697X0738251001: XPRESS SYSTEM PEDICLE SCREW ASSY, 8.25 x 100mm
• M697X0737595DL1: XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 95mm
• M697X07375951: XPRESS SYSTEM PEDICLE SCREW ASSY, 7.5 x 95mm
• M697X0737590DL1: XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 90mm
• M697X07375901: XPRESS SYSTEM PEDICLE SCREW ASSY, 7.5 x 90mm
• M697X0737585DL1: XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 85mm
• M697X07375851: XPRESS SYSTEM PEDICLE SCREW ASSY, 7.5 x 85mm
• M697X0737580DL1: XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 80mm
• M697X07375801: XPRESS SYSTEM PEDICLE SCREW ASSY, 7.5 x 80mm
• M697X0737575DL1: XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 75mm
• M697X07375751: XPRESS SYSTEM PEDICLE SCREW ASSY, 7.5 x 75mm
• M697X0737570DL1: XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 70mm
• M697X07375701: XPRESS SYSTEM PEDICLE SCREW ASSY, 7.5 x 70mm
• M697X0737565DL1: XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 65mm
• M697X07375651: XPRESS SYSTEM PEDICLE SCREW ASSY, 7.5 x 65mm
• M697X0737560DL1: XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 60mm
• M697X07375601: XPRESS SYSTEM PEDICLE SCREW ASSY, 7.5 x 60mm
• M697X0737555DL1: XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 55mm
• M697X07375551: XPRESS SYSTEM PEDICLE SCREW ASSY, 7.5 x 55mm
• M697X0737550DL1: XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 50mm
• M697X07375501: XPRESS SYSTEM PEDICLE SCREW ASSY, 7.5 x 50mm
• M697X0737545DL1: XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 45mm
• M697X07375451: XPRESS SYSTEM PEDICLE SCREW ASSY, 7.5 x 45mm
• M697X0737540DL1: XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 40mm
• M697X07375401: XPRESS SYSTEM PEDICLE SCREW ASSY, 7.5 x 40mm
• M697X0737535DL1: XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 35mm
• M697X07375351: XPRESS SYSTEM PEDICLE SCREW ASSY, 7.5 x 35mm
• M697X0737530DL1: XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 30mm
• M697X07375301: XPRESS SYSTEM PEDICLE SCREW ASSY, 7.5 x 30mm
• M697X07375100DL1: XPRESS SYSTEM PEDICLE SCREW ASSY, DUAL LEAD, 7.5 x 100mm