Xsert Lumbar Expandable Interbody System

GUDID M697X0921210240

12mm-17mm x 10mm x 24mm PLIF ASSY

X-SPINE SYSTEMS, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: M697X0921210240
• NIH Device Record Key: 80345298-bdca-46d4-831a-6f661086dbbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xsert Lumbar Expandable Interbody System
• Version Model Number: X092-121024
• 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

• Width: 10 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 10 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 10 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 10 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 10 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 10 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 10 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 10 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 10 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 10 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 10 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 10 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 10 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 10 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 10 Millimeter
• Length: 24 Millimeter
• Device Size Text, specify: 0
• Width: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M697X0921210240 [Direct Marking]
HIBCC	M697X0921210241 [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

[M697X0921210240]

Moist Heat or Steam Sterilization

[M697X0921210240]

Moist Heat or Steam Sterilization

[M697X0921210240]

Moist Heat or Steam Sterilization

[M697X0921210240]

Moist Heat or Steam Sterilization

[M697X0921210240]

Moist Heat or Steam Sterilization

[M697X0921210240]

Moist Heat or Steam Sterilization

[M697X0921210240]

Moist Heat or Steam Sterilization

[M697X0921210240]

Moist Heat or Steam Sterilization

[M697X0921210240]

Moist Heat or Steam Sterilization

[M697X0921210240]

Moist Heat or Steam Sterilization

[M697X0921210240]

Moist Heat or Steam Sterilization

[M697X0921210240]

Moist Heat or Steam Sterilization

[M697X0921210240]

Moist Heat or Steam Sterilization

[M697X0921210240]

Moist Heat or Steam Sterilization

[M697X0921210240]

Moist Heat or Steam Sterilization

[M697X0921210240]

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