ReLine

GUDID 00887517037855

RELINE-O Screw+LS, 8.5x35mm 2 Fen Poly

Nuvasive, Inc.

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 00887517037855
• NIH Device Record Key: 39fbde23-4b94-4b9b-92fc-73d372553948
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReLine
• Version Model Number: 13228535P
• Company DUNS: 053950783
• Company Name: Nuvasive, 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(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com
• Phone: +1(858)909-1800
• Email: RA_UDI@nuvasive.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887517037855 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180498

FDA Product Code

• PML: bone cement, posterior screw augmentation

Sterilization

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

[00887517037855]

Radiation Sterilization

[00887517037855]

Radiation Sterilization

[00887517037855]

Radiation Sterilization

[00887517037855]

Radiation Sterilization

[00887517037855]

Radiation Sterilization

[00887517037855]

Radiation Sterilization

[00887517037855]

Radiation Sterilization

[00887517037855]

Radiation Sterilization

[00887517037855]

Radiation Sterilization

[00887517037855]

Radiation Sterilization

[00887517037855]

Radiation Sterilization

[00887517037855]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-05
• Device Publish Date: 2021-02-25

On-Brand Devices [ReLine]

• 00887517545916: RELINE-O Screw, 6.5x85mm 2S Uniplanar
• 00887517545909: RELINE-O Screw, 6.5x80mm 2S Uniplanar
• 00887517545893: RELINE-O Screw, 6.5x75mm 2S Uniplanar
• 00887517545886: RELINE-O Screw, 6.5x70mm 2S Uniplanar
• 00887517545879: RELINE-O Screw, 6.5x65mm 2S Uniplanar
• 00887517545862: RELINE-O Screw, 6.5x60mm 2S Uniplanar
• 00887517545855: RELINE-O Screw, 6.5x55mm 2S Uniplanar
• 00887517545848: RELINE-O Screw, 6.5x50mm 2S Uniplanar
• 00887517545831: RELINE-O Screw, 6.5x45mm 2S Uniplanar
• 00887517545824: RELINE-O Screw, 6.5x40mm 2S Uniplanar
• 00887517545817: RELINE-O Screw, 6.5x35mm 2S Uniplanar
• 00887517545800: RELINE-O Screw, 6.5x30mm 2S Uniplanar
• 00887517545794: RELINE-O Screw, 6.5x25mm 2S Uniplanar
• 00887517545787: RELINE-O Screw, 6.5x120mm 2S Uniplanar
• 00887517545770: RELINE-O Screw, 6.5x110mm 2S Uniplanar
• 00887517545763: RELINE-O Screw, 6.5x100mm 2S Uniplanar
• 00887517545756: RELINE-O Screw, 6.0x95mm 2S Uniplanar
• 00887517545749: RELINE-O Screw, 6.0x90mm 2S Uniplanar
• 00887517545732: RELINE-O Screw, 6.0x85mm 2S Uniplanar
• 00887517545725: RELINE-O Screw, 6.0x80mm 2S Uniplanar
• 00887517545718: RELINE-O Screw, 6.0x75mm 2S Uniplanar
• 00887517545701: RELINE-O Screw, 6.0x70mm 2S Uniplanar
• 00887517545695: RELINE-O Screw, 6.0x65mm 2S Uniplanar
• 00887517545688: RELINE-O Screw, 6.0x60mm 2S Uniplanar
• 00887517545671: RELINE-O Screw, 6.0x55mm 2S Uniplanar
• 00887517545664: RELINE-O Screw, 6.0x50mm 2S Uniplanar
• 00887517545657: RELINE-O Screw, 6.0x45mm 2S Uniplanar
• 00887517545640: RELINE-O Screw, 6.0x40mm 2S Uniplanar
• 00887517545633: RELINE-O Screw, 6.0x35mm 2S Uniplanar
• 00887517545626: RELINE-O Screw, 6.0x30mm 2S Uniplanar
• 00887517545619: RELINE-O Screw, 6.0x25mm 2S Uniplanar
• 00887517545602: RELINE-O Screw, 6.0x120mm 2S Uniplanar
• 00887517545596: RELINE-O Screw, 6.0x110mm 2S Uniplanar
• 00887517545589: RELINE-O Screw, 6.0x100mm 2S Uniplanar
• 00887517545572: RELINE-O Screw, 5.5x95mm 2S Uniplanar
• 00887517545565: RELINE-O Screw, 5.5x90mm 2S Uniplanar
• 00887517545558: RELINE-O Screw, 5.5x85mm 2S Uniplanar
• 00887517545541: RELINE-O Screw, 5.5x80mm 2S Uniplanar
• 00887517545534: RELINE-O Screw, 5.5x75mm 2S Uniplanar
• 00887517545527: RELINE-O Screw, 5.5x70mm 2S Uniplanar
• 00887517545510: RELINE-O Screw, 5.5x65mm 2S Uniplanar
• 00887517545503: RELINE-O Screw, 5.5x60mm 2S Uniplanar
• 00887517545497: RELINE-O Screw, 5.5x55mm 2S Uniplanar
• 00887517545480: RELINE-O Screw, 5.5x50mm 2S Uniplanar
• 00887517545473: RELINE-O Screw, 5.5x45mm 2S Uniplanar
• 00887517545466: RELINE-O Screw, 5.5x40mm 2S Uniplanar
• 00887517545459: RELINE-O Screw, 5.5x35mm 2S Uniplanar
• 00887517545442: RELINE-O Screw, 5.5x30mm 2S Uniplanar
• 00887517545435: RELINE-O Screw, 5.5x25mm 2S Uniplanar
• 00887517545428: RELINE-O Screw, 5.5x120mm 2S Uniplanar