XPAND-R

GUDID 00849044086614

XPand-R Corpectomy Spacer Small 13x15 3.5/3.5deg, 58-66mm

GLOBUS MEDICAL, INC.

Vertebral body prosthesis

• Primary Device ID: 00849044086614
• NIH Device Record Key: 1a087bf7-7529-4fcb-ae05-cc87ce9b2a1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XPAND-R
• Version Model Number: 316.121
• Company DUNS: 139105691
• Company Name: GLOBUS MEDICAL, 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(610)930-1800
• Email: info@globusmedical.com

Device Dimensions

• Depth: 13 Millimeter
• Depth: 13 Millimeter
• Depth: 13 Millimeter
• Depth: 13 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849044086614 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060665

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[00849044086614]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-10-09

On-Brand Devices [XPAND-R]

• 00849044087376: XPand-R Corpectomy Spacer Med-Wide 23x26 8/8°, 82-92mm
• 00849044087369: XPand-R Corpectomy Spacer Med-Wide 23x26 8/8°, 73-83mm
• 00849044087352: XPand-R Corpectomy Spacer Med-Wide 23x26 8/8°, 66-76mm
• 00849044087345: XPand-R Corpectomy Spacer Med-Wide 23x26 8/8°, 58-68mm
• 00849044087338: XPand-R Corpectomy Spacer Med-Wide 23x26 8/8°, 48-58mm
• 00849044087321: XPand-R Corpectomy Spacer Med-Wide 23x26 8/8°, 40-48mm
• 00849044087314: XPand-R Corpectomy Spacer Med-Wide 23x26 8/8°, 36-40mm
• 00849044087307: XPand-R Corpectomy Spacer Med-Wide 23x26 8/8°, 35-37mm
• 00849044087291: XPand-R Corpectomy Spacer Med-Wide 23x26 4/4°, 82-92mm
• 00849044087284: XPand-R Corpectomy Spacer Med-Wide 23x26 4/4°, 73-83mm
• 00849044087277: XPand-R Corpectomy Spacer Med-Wide 23x26 4/4°, 64-74mm
• 00849044087260: XPand-R Corpectomy Spacer Med-Wide 23x26 4/4°, 56-66mm
• 00849044087253: XPand-R Corpectomy Spacer Med-Wide 23x26 4/4°, 46-56mm
• 00849044087246: XPand-R Corpectomy Spacer Med-Wide 23x26 4/4°, 38-46mm
• 00849044087239: XPand-R Corpectomy Spacer Med-Wide 23x26 4/4°, 34-38mm
• 00849044087222: XPand-R Corpectomy Spacer Med-Wide 23x26 4/4°, 32-34mm
• 00849044087215: XPand-R Corpectomy Spacer Med-Wide 23x26 0°, 82-92mm
• 00849044087208: XPand-R Corpectomy Spacer Med-Wide 23x26 0°, 73-83mm
• 00849044087192: XPand-R Corpectomy Spacer Med-Wide 23x26 0°, 64-74mm
• 00849044087185: XPand-R Corpectomy Spacer Med-Wide 23x26 0°, 56-66mm
• 00849044087178: XPand-R Corpectomy Spacer Med-Wide 23x26 0°, 46-56mm
• 00849044087161: XPand-R Corpectomy Spacer Med-Wide 23x26 0°, 38-46mm
• 00849044087154: XPand-R Corpectomy Spacer Med-Wide 23x26 0°, 34-38mm
• 00849044087147: XPand-R Corpectomy Spacer Med-Wide 23x26 0°, 32-34mm
• 00849044087130: XPand -R Corpectomy Spacer Medium-L 21x23/25x30, 0/3deg, 28-34mmS
• 00849044087123: XPand -R Corpectomy Spacer Medium-L 21x23/25x30, 0deg, 28-34mmS
• 00849044087116: XPand-R Corpectomy Spacer Medium-L 25x30 0/3deg, 61-70mmE
• 00849044087109: XPand-R Corpectomy Spacer Medium-L 25x30 0/3deg, 55-64mmE
• 00849044087093: XPand-R Corpectomy Spacer Medium-L 25x30 0/3deg, 45-54mmE
• 00849044087086: XPand-R Corpectomy Spacer Medium-L 25x30 0/3deg, 39-46mmE
• 00849044087079: XPand-R Corpectomy Spacer Medium-L 25x30 0/3deg, 35-38mmE
• 00849044087062: XPand-R Corpectomy Spacer Medium-L 25x30 0/3deg, 28-34mmE
• 00849044087055: XPand-R Corpectomy Spacer Medium-L 25x30 0deg, 61-70mmE
• 00849044087048: XPand-R Corpectomy Spacer Medium-L 25x30 0deg, 55-64mmE
• 00849044087031: XPand-R Corpectomy Spacer Medium-L 25x30 0deG, 45-54mmE
• 00849044087024: XPand-R Corpectomy Spacer Medium-L 25x30 0deg, 39-46mmE
• 00849044087017: XPand-R Corpectomy Spacer Medium-L 25x30 0deg, 35-38mmE
• 00849044087000: XPand-R Corpectomy Spacer Medium-L 25x30 0deg, 28-34mmE
• 00849044086997: XPand -R Corpectomy Spacer, Small-M, 21x23, 0deg, 24-28mmS
• 00849044086980: XPand -R Corpectomy Spacer, Small-M, 21x23, 0deg, 23-26mmS
• 00849044086973: XPand-R Corpectomy Spacer Small-M 21x23 0deG, 30-32mmE
• 00849044086966: XPand-R Corpectomy Spacer Small-M 21x23 0deg, 24-28mmE
• 00849044086959: XPand-R Corpectomy Spacer Small-M 21x23 0deg, 23-26mmE
• 00849044086942: XPand -R Corpectomy Spacer, Medium, 21x23, 0deg, 82-92mm
• 00849044086935: XPand -R Corpectomy Spacer, Medium, 21x23, 0deG, 73-83mm
• 00849044086928: XPand -R Corpectomy Spacer, Medium, 21x23, 4/4deg, 82-92mm
• 00849044086911: XPand -R Corpectomy Spacer, Medium, 21x23, 4/4deg, 73-83mm
• 00849044086904: XPand -R Corpectomy Spacer, Medium, 21x23, 4/4deg, 64-74mm
• 00849044086898: XPand -R Corpectomy Spacer, Medium, 21x23, 4/4deg, 56-66mm
• 00849044086881: XPand -R Corpectomy Spacer, Medium, 21x23, 4/4deg, 46-56mm