Xsert Lumbar Expandable Interbody System

GUDID M697X0920910320

9mm-13mm x 10mm x 32mm PLIF ASSY

X-SPINE SYSTEMS, INC.

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: M697X0920910320
• NIH Device Record Key: f6003bfd-8462-4896-8b63-c3c5d6c006f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xsert Lumbar Expandable Interbody System
• Version Model Number: X092-091032
• Company DUNS: 610042587
• Company Name: X-SPINE SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• 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(937)847-8400
• Email: orders@x-spine.com

Device Dimensions

• Device Size Text, specify: 0
• Length: 32 Millimeter
• Width: 10 Millimeter
• Device Size Text, specify: 0
• Length: 32 Millimeter
• Width: 10 Millimeter
• Device Size Text, specify: 0
• Length: 32 Millimeter
• Width: 10 Millimeter
• Device Size Text, specify: 0
• Length: 32 Millimeter
• Width: 10 Millimeter
• Device Size Text, specify: 0
• Length: 32 Millimeter
• Width: 10 Millimeter
• Device Size Text, specify: 0
• Length: 32 Millimeter
• Width: 10 Millimeter
• Device Size Text, specify: 0
• Length: 32 Millimeter
• Width: 10 Millimeter
• Device Size Text, specify: 0
• Length: 32 Millimeter
• Width: 10 Millimeter
• Device Size Text, specify: 0
• Length: 32 Millimeter
• Width: 10 Millimeter
• Device Size Text, specify: 0
• Length: 32 Millimeter
• Width: 10 Millimeter
• Device Size Text, specify: 0
• Length: 32 Millimeter
• Width: 10 Millimeter
• Device Size Text, specify: 0
• Length: 32 Millimeter
• Width: 10 Millimeter
• Device Size Text, specify: 0
• Length: 32 Millimeter
• Width: 10 Millimeter
• Device Size Text, specify: 0
• Length: 32 Millimeter
• Width: 10 Millimeter
• Device Size Text, specify: 0
• Length: 32 Millimeter
• Width: 10 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M697X0920910320 [Direct Marking]
HIBCC	M697X0920910321 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160959

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[M697X0920910320]

Moist Heat or Steam Sterilization

[M697X0920910320]

Moist Heat or Steam Sterilization

[M697X0920910320]

Moist Heat or Steam Sterilization

[M697X0920910320]

Moist Heat or Steam Sterilization

[M697X0920910320]

Moist Heat or Steam Sterilization

[M697X0920910320]

Moist Heat or Steam Sterilization

[M697X0920910320]

Moist Heat or Steam Sterilization

[M697X0920910320]

Moist Heat or Steam Sterilization

[M697X0920910320]

Moist Heat or Steam Sterilization

[M697X0920910320]

Moist Heat or Steam Sterilization

[M697X0920910320]

Moist Heat or Steam Sterilization

[M697X0920910320]

Moist Heat or Steam Sterilization

[M697X0920910320]

Moist Heat or Steam Sterilization

[M697X0920910320]

Moist Heat or Steam Sterilization

[M697X0920910320]

Moist Heat or Steam Sterilization

[M697X0920910320]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-24
• Device Publish Date: 2017-04-01

On-Brand Devices [Xsert Lumbar Expandable Interbody System]

• M697X092121032STR0: 12mm-17mm x 10mm x 32mm PLIF ASSY (STERILE)
• M697X0921210320: 12mm-17mm x 10mm x 32mm PLIF ASSY
• M697X092121026STR0: 12mm-17mm x 10mm x 26mm PLIF ASSY (STERILE)
• M697X0921210265STR0: 12mm-17mm x 10mm x 26mm x 5° PLIF ASSY (STERILE)
• M697X09212102650: 12mm-17mm x 10mm x 26mm x 5° PLIF ASSY
• M697X09212102610STR0: 12mm-17mm x 10mm x 26mm x 10° PLIF ASSY (STERILE)
• M697X092121026100: 12mm-17mm x 10mm x 26mm x 10° PLIF ASSY
• M697X0921210260: 12mm-17mm x 10mm x 26mm PLIF ASSY
• M697X092121024STR0: 12mm-17mm x 10mm x 24mm PLIF ASSY (STERILE)
• M697X0921210245STR0: 12mm-17mm x 10mm x 24mm x 5° PLIF ASSY (STERILE)
• M697X09212102450: 12mm-17mm x 10mm x 24mm x 5° PLIF ASSY
• M697X09212102410STR0: 12mm-17mm x 10mm x 24mm x 10° PLIF ASSY (STERILE)
• M697X092121024100: 12mm-17mm x 10mm x 24mm x 10° PLIF ASSY
• M697X0921210240: 12mm-17mm x 10mm x 24mm PLIF ASSY
• M697X092091032STR0: 9mm-13mm x 10mm x 32mm PLIF ASSY (STERILE)
• M697X0920910320: 9mm-13mm x 10mm x 32mm PLIF ASSY
• M697X092091026STR0: 9mm-13mm x 10mm x 26mm PLIF ASSY (STERILE)
• M697X0920910265STR0: 9mm-13mm x 10mm x 26mm x 5° PLIF ASSY (STERILE)
• M697X09209102650: 9mm-13mm x 10mm x 26mm x 5° PLIF ASSY
• M697X0920910260: 9mm-13mm x 10mm x 26mm PLIF ASSY
• M697X092091024STR0: 9mm-13mm x 10mm x 24mm PLIF ASSY (STERILE)
• M697X0920910245STR0: 9mm-13mm x 10mm x 24mm x 5° PLIF ASSY (STERILE)
• M697X09209102450: 9mm-13mm x 10mm x 24mm x 5° PLIF ASSY
• M697X0920910240: 9mm-13mm x 10mm x24mm PLIF ASSY
• M697X092071032STR0: 7mm-10mm x 10mm x 32mm PLIF ASSY (Sterile)
• M697X0920710320: 7mm-10mm x 10mm x 32mm PLIF ASSY
• M697X092071026STR0: 7mm-10mm x 10mm 26mm PLIF ASSY (Sterile)
• M697X0920710260: 7mm-10mm x 10mm 26mm PLIF ASSY
• M697X092071024STR0: 7mm-10mm x 10mm x 24mm PLIF ASSY (Sterile)
• M697X0920710240: 7mm-10mm x 10mm x 24mm PLIF ASSY
• M697X09200060: Xsert Posterior Disc Prep Sterilization Case
• M697X09200050: Xsert Instrument Sterilization Case
• M697X09200020: Xsert Posterior Disc Prep set
• M697X09200010: Xsert Instrument Set
• M697T09219000: SLAP HAMMER
• M697T09218000: RE-ENGAGEMENT GUIDE
• M697T09217000: TAMP
• M697T09216000: TORRQUE LIMITING HANDLE
• M697T09215000: FIXED HANDLE
• M697T09214000: GRAFT PACKING BLOCK
• M697T09211000: ELEVATOR
• M697T092100070: ANGLED RING CURETTE
• M697T092100060: LATERAL RIGHT CURETTE
• M697T092100050: LATERAL LEFT CURETTE
• M697T092100040: REVERSE ANGLED CURETTE
• M697T092100030: ANGLED CURETTE
• M697T092100020: DOWN PUSHING CURETTE
• M697T092100010: STRAIGHT CURETTE
• M697T092090020: CURVED OSTEOTOME
• M697T092090010: STRAIGHT OSTEOTOME