ALTERA

GUDID 00889095069914

ALTERA Spacer, 10 x 36, 12-16mm, 8°

GLOBUS MEDICAL, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00889095069914
• NIH Device Record Key: ecb48890-f0ec-4f44-801f-0113d97f4938
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALTERA
• Version Model Number: 1124.1215
• 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

• Length: 36 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889095069914 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140411

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00889095069914]

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: 2015-10-30

On-Brand Devices [ALTERA]

• 00889095174595: ALTERA Removal Threaded Rod
• 00889095174571: ALTERA Inserter Driver Shaft
• 00889095174564: ALTERA Inserter Threaded Rod
• 00889095174557: ALTERA Inserter Sleeve
• 00889095174540: ALTERA Inserter Base
• 00889095258363: ALTERA Spacer, 10 x 26, 9-13mm, 8°
• 00889095258356: ALTERA Spacer, 10 x 26, 8-12mm, 8°
• 00889095069976: ALTERA Spacer, 10 x 36, 12-16mm, 15°
• 00889095069952: ALTERA Spacer, 10 x 36, 10-14mm, 15°
• 00889095069945: ALTERA Spacer, 10 x 36, 9-13mm, 15°
• 00889095069914: ALTERA Spacer, 10 x 36, 12-16mm, 8°
• 00889095069891: ALTERA Spacer, 10 x 36, 10-14mm, 8°
• 00889095069884: ALTERA Spacer, 10 x 36, 9-13mm, 8°
• 00889095069877: ALTERA Spacer, 10 x 36, 8-12mm, 8°
• 00889095069778: ALTERA Spacer, 10 x 31, 12-16mm, 15°
• 00889095069754: ALTERA Spacer, 10 x 31, 10-14mm, 15°
• 00889095069747: ALTERA Spacer, 10 x 31, 9-13mm, 15°
• 00889095069716: ALTERA Spacer, 10 x 31, 12-16mm, 8°
• 00889095069693: ALTERA Spacer, 10 x 31, 10-14mm, 8°
• 00889095069686: ALTERA Spacer, 10 x 31, 9-13mm, 8°
• 00889095069679: ALTERA Spacer, 10 x 31, 8-12mm, 8°
• 00889095069570: ALTERA Spacer, 10 x 26, 12-16mm, 15°
• 00889095069556: ALTERA Spacer, 10 x 26, 10-14mm, 15°
• 00889095069549: ALTERA Spacer, 10 x 26, 9-13mm, 15°
• 00889095069518: ALTERA Spacer, 10 x 26, 12-16mm, 8°
• 00889095069495: ALTERA Spacer, 10 x 26, 10-14mm, 8°