X90 Pedicle Screw System

GUDID M697N60000621DL1

Assembly, X90, 7.5 x 45, Dual Lead, Cannulated screw

Xtant Medical Holdings, Inc.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: M697N60000621DL1
• NIH Device Record Key: f08facd6-543d-452b-87ca-cd5ea37d9faa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X90 Pedicle Screw System
• Version Model Number: N60000621-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: true
• 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

Device Dimensions

• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 45 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M697N60000621DL1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052847

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

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

[M697N60000621DL1]

Moist Heat or Steam Sterilization

[M697N60000621DL1]

Moist Heat or Steam Sterilization

[M697N60000621DL1]

Moist Heat or Steam Sterilization

[M697N60000621DL1]

Moist Heat or Steam Sterilization

[M697N60000621DL1]

Moist Heat or Steam Sterilization

[M697N60000621DL1]

Moist Heat or Steam Sterilization

[M697N60000621DL1]

Moist Heat or Steam Sterilization

[M697N60000621DL1]

Moist Heat or Steam Sterilization

[M697N60000621DL1]

Moist Heat or Steam Sterilization

[M697N60000621DL1]

Moist Heat or Steam Sterilization

[M697N60000621DL1]

Moist Heat or Steam Sterilization

[M697N60000621DL1]

Moist Heat or Steam Sterilization

[M697N60000621DL1]

Moist Heat or Steam Sterilization

[M697N60000621DL1]

Moist Heat or Steam Sterilization

[M697N60000621DL1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-06-03
• Device Publish Date: 2015-09-30

On-Brand Devices [X90 Pedicle Screw System]

• M697N607555SDDL1: Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 7.5 x 55
• M697N607555SD1: Assembly, X90, 7.5 x 55 Self-Drilling Screw
• M697N607550SDDL1: Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 7.5 x 50
• M697N607550SD1: Assembly, X90, 7.5 x 50 Self-Drilling Screw
• M697N607545SDDL1: Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 7.5 x 45
• M697N607545SD1: Assembly, X90, 7.5 x 45 Self-Drilling Screw
• M697N607540SDDL1: Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 7.5 x 40
• M697N607540SD1: Assembly, X90, 7.5 x 40 Self-Drilling Screw
• M697N607535SDDL1: Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 7.5 x 35
• M697N607535SD1: Assembly, X90, 7.5 x 35 Self-Drilling Screw
• M697N607530SDDL1: Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 7.5 x 30
• M697N607530SD1: Assembly, X90, 7.5 x 30 Self-Drilling Screw
• M697N606555SDDL1: Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 6.5 x 55
• M697N606555SD1: Assembly, X90, 6.5 x 55 Self-Drilling Screw
• M697N606550SDDL1: Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 6.5 x 50
• M697N606550SD1: Assembly, X90, 6.5 x 50 Self-Drilling Screw
• M697N606545SDDL1: Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 6.5 x 45
• M697N606545SD1: Assembly, X90, 6.5 x 45 Self-Drilling Screw
• M697N606540SDDL1: Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 6.5 x 40
• M697N606540SD1: Assembly, X90, 6.5 x 40 Self-Drilling Screw
• M697N606535SDDL1: Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 6.5 x 35
• M697N606535SD1: Assembly, X90, 6.5 x 35 Self-Drilling Screw
• M697N606530SDDL1: Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 6.5 x 30
• M697N606530SD1: Assembly, X90, 6.5 x 30 Self-Drilling Screw
• M697N605555SDDL1: Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 5.5 x 55
• M697N605555SD1: Assembly, X90, 5.5 x 55 Self-Drilling Screw
• M697N605550SDDL1: Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 5.5 x 50
• M697N605550SD1: Assembly, X90, 5.5 x 50 Self-Drilling Screw
• M697N605545SDDL1: Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 5.5 x 45
• M697N605545SD1: Assembly, X90, 5.5 x 45 Self-Drilling Screw
• M697N605540SDDL1: Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 5.5 x 40
• M697N605540SD1: Assembly, X90, 5.5 x 40 Self-Drilling Screw
• M697N605535SDDL1: Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 5.5 x 35
• M697N605535SD1: Assembly, X90, 5.5 x 35 Self-Drilling Screw
• M697N605530SDDL1: Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 5.5 x 30
• M697N605530SD1: Assembly, X90, 5.5 x 30 Self-Drilling Screw
• M697N600022010: Sterilization Case, 5.5mm Rod, Instrument
• M697N600022000: 5.5mm Rod Instrument Set
• M697N600021050: Cross Connector Caddy, X90
• M697N600021040: Rod Caddy, X90
• M697N600021030: Sterilization Case, X90, Instrument
• M697N600021020: Sterilization Case, X90, Implant
• M697N600016200: Twist Driver, Assembly
• M697N600016100: Flex Locking Screwdriver, X90, Assy
• M697N600015780: CAM SCREWDRIVER THUMB WHEEL
• M697N600015770: CAM SCREWDRIVER FORK SLEEVE
• M697N600015760: CAM SCREWDRIVER HEX SHAFT
• M697N600015750: CAM SCREWDRIVER ASSEMBLY
• M697N600015540: FINAL LOCKING WRENCH, 1/4" SQUARE
• M697N600015530: PROVISIONAL LOCKING WRENCH, 1/4" SQUARE