Armada

GUDID 00887517302717

ARM15S Screw, 8.5x35mm Polyaxial

Nuvasive, Inc.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00887517302717
• NIH Device Record Key: 58eaf5a1-e4d3-4df0-8237-ed8a91b57dd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Armada
• Version Model Number: 8558535
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887517302717 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092287

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

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

[00887517302717]

Moist Heat or Steam Sterilization

[00887517302717]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [Armada]

• 00887517517005: Armada Extended Screwdrivers and Taps
• 00887517516985: Armada Vertebral Body Derotation
• 00887517516978: Armada SS Adjacent Segment Fixation
• 00887517516961: Armada Short Screwdrivers and Taps
• 00887517516930: Armada Rod Cutter Tray
• 00887517516923: Armada Colbalt Chrome Rod Tray
• 00887517516916: Armada 5.5mm Ti Uniplanar Screw Imp Set
• 00887517516909: Armada Reduction Uniplanar Screw Tray
• 00887517516862: Armada 5.5Ti Reduction Screw Set
• 00887517516855: Armada 5.5Ti Open Iliac Imp Set
• 00887517516848: Armada 5.5mm Ti Low Profile Hooks
• 00887517516831: Armada Low Pro X-Connectors, 5.5mm Ti
• 00887517516824: Armada Large Sized Screws, 5.5mm Ti
• 00887517516817: Armada 5.5mm Ti Long Rod Imp Set
• 00887517516756: Armada 5.5mm Ti Iliac Imp Set
• 00887517516695: Armada 5.5Ti Screw/Hook Set
• 00887517516664: Armada 5.5Ti Extended Poly Implant Set
• 00887517516602: Armada 5.5Ti Degen Imp Set
• 00887517516596: Armada 5.5Ti Deform Imp Set
• 00887517516572: Armada 5.5mm Ti Cross Connector Set
• 00887517516558: Armada 5.5mm Uniplanar Screw Imp Set
• 00887517516541: Armada 5.5mm SS Reduction Uni Screw Tray
• 00887517516534: Armada 5.5mm Reduction Screw Imp Set
• 00887517516527: Armada 5.5mm SS Polyaxl Screw Imp Set
• 00887517516510: Armada 5.5mm SS PLS Imp Set
• 00887517516503: Armada 5.5mm SS Iliac Screw Imp Set
• 00887517516497: Armada 5.5mm SS Fix Screw & Hook Imp Set
• 00887517516480: Armada 5.5mm SS Cross Connector Imp Set
• 00887517516435: Armada 5.5mm Degen Ins Tray 2
• 00887517516381: Armada Degen Ins Tray 1
• 00887517516367: Armada 5.5mm Deform Ins Tray 2
• 00887517516329: Armada 5.5mm Deform Ins Tray 1
• 00887517516312: Armada 3-Column Osteotomy Tray
• 00887517514974: Alpha Armada Vertebral Body Derotation
• 00887517514950: ALPHA Armada Imp Tray 3, 6.35mm SS
• 00887517514943: ALPHA Armada Imp Tray 2, 6.35mm SS
• 00887517514936: ALPHA Armada Imp Tray 1, 6.35mm SS
• 00887517514929: ALPHA Armada InsTray 5, 6.35mm
• 00887517514912: ALPHA Armada Ins Tray 4, 6.35mm
• 00887517514905: ALPHA Armada Ins Tray 3, 6.35mm
• 00887517514899: ALPHA Armada Ins Tray 2, 6.35mm
• 00887517514882: ALPHA Armada Ins Tray 1, 6.35mm
• 00887517486585: ARM15S Dismantlable Reduction Driver
• 00887517486578: ArmadaTi Screwdriver, Poly Dismantlable
• 00887517485502: Armada Ti Tap, 9.5mm Single Lead
• 00887517485496: Armada Ti Tap, 8.5mm Single Lead
• 00887517485489: Armada Ti Tap, 7.5mm Single Lead
• 00887517485472: Armada Ti Tap, 6.5mm Single Lead
• 00887517485465: Armada Ti Tap, 5.5mm Single Lead
• 00887517485458: Armada Ti Tap, 5.0mm Single Lead