ALTERA

GUDID 00889095174540

ALTERA Inserter Base

GLOBUS MEDICAL, INC.

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00889095174540
• NIH Device Record Key: 92107632-b9ee-4f6d-ac60-cab7a5a58436
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALTERA
• Version Model Number: 6124.0001
• 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889095174540 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140411

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[00889095174540]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-10-07

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°