H-LINK

GUDID 00849044023299

H-LINK 06.35mm Rod, 38mm-51mm x 45mm

GLOBUS MEDICAL, INC.

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 00849044023299
• NIH Device Record Key: 8ddb6849-b52a-4cc8-bba4-f32a6e16b3b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: H-LINK
• Version Model Number: 172.621
• 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

• Outer Diameter: 6.35 Millimeter
• Outer Diameter: 6.35 Millimeter
• Outer Diameter: 6.35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849044023299 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073517

FDA Product Code

• NKB: Orthosis, spinal pedicle fixation, for degenerative disc disease

Sterilization

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

[00849044023299]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-11-06

On-Brand Devices [H-LINK]

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• 00849044049763: H-LINK 05.5mm Rod, 48mm-61mm x 35mm
• 00849044049756: H-LINK 05.5mm Rod, 38mm-51mm x 35mm
• 00849044023343: H-LINK 06.35mm Rod, 58mm-71mm x 100mm
• 00849044023336: H-LINK 06.35mm Rod, 48mm-61mm x 100mm
• 00849044023329: H-LINK 06.35mm Rod, 38mm-51mm x 100mm
• 00849044023312: H-LINK 06.35mm Rod, 58mm-71mm x 45mm
• 00849044023305: H-LINK 06.35mm Rod, 48mm-61mm x 45mm
• 00849044023299: H-LINK 06.35mm Rod, 38mm-51mm x 45mm
• 00849044023282: H-LINK 06.35mm Rod, 58mm-71mm x 40mm
• 00849044023275: H-LINK 06.35mm Rod, 48mm-61mm x 40mm
• 00849044023268: H-LINK 06.35mm Rod, 38mm-51mm x 40mm
• 00849044023251: H-LINK 05.5mm Rod, 58mm-71mm x 100mm
• 00849044023244: H-LINK 05.5mm Rod, 48mm-61mm x 100mm
• 00849044023237: H-LINK 05.5mm Rod, 38mm-51mm x 100mm
• 00849044023220: H-LINK 05.5mm Rod, 58mm-71mm x 45mm
• 00849044023213: H-LINK 05.5mm Rod, 48mm-61mm x 45mm
• 00849044023206: H-LINK 05.5mm Rod, 38mm-51mm x 45mm
• 00849044023190: H-LINK 05.5mm Rod, 58mm-71mm x 40mm
• 00849044023183: H-LINK 05.5mm Rod, 48mm-61mm x 40mm
• 00849044023176: H-LINK 05.5mm Rod, 38mm-51mm x 40mm