Monolith

GUDID 00887517698018

Monolith Core, Ø14x34mm

Nuvasive, Inc.

Vertebral body prosthesis, non-sterile

• Primary Device ID: 00887517698018
• NIH Device Record Key: e7260de9-dfdc-4f3a-99e2-860bcc891b19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monolith
• Version Model Number: 5991434
• 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: 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: 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
• 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	00887517698018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151538

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[00887517698018]

Moist Heat or Steam Sterilization

[00887517698018]

Moist Heat or Steam Sterilization

[00887517698018]

Moist Heat or Steam Sterilization

[00887517698018]

Moist Heat or Steam Sterilization

[00887517698018]

Moist Heat or Steam Sterilization

[00887517698018]

Moist Heat or Steam Sterilization

[00887517698018]

Moist Heat or Steam Sterilization

[00887517698018]

Moist Heat or Steam Sterilization

[00887517698018]

Moist Heat or Steam Sterilization

[00887517698018]

Moist Heat or Steam Sterilization

[00887517698018]

Moist Heat or Steam Sterilization

[00887517698018]

Moist Heat or Steam Sterilization

[00887517698018]

Moist Heat or Steam Sterilization

[00887517698018]

Moist Heat or Steam Sterilization

[00887517698018]

Moist Heat or Steam Sterilization

[00887517698018]

Moist Heat or Steam Sterilization

[00887517698018]

Moist Heat or Steam Sterilization

[00887517698018]

Moist Heat or Steam Sterilization

[00887517698018]

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: 2016-05-23

On-Brand Devices [Monolith]

• 00887517677730: Monolith Inserter
• 00887517677433: Monolith Calipers
• 00887517706218: Monolith Corpectomy Instrument Tray
• 00887517706201: Monolith Corpectomy 14mm 3 Level
• 00887517706195: Monolith Corpectomy 14mm Implant Tray
• 00887517706188: Monolith Corpectomy 12mm 3 Level
• 00887517706171: Monolith Corpectomy 12mm Implant Tray
• 00887517698261: Monolith Endcap, 19x16mm Lord 15° Ø14
• 00887517698254: Monolith Endcap, 17x15mm Lord 15° Ø14
• 00887517698247: Monolith Endcap, 17x14mm Lord 15° Ø12
• 00887517698230: Monolith Endcap, 15x13mm Lord 15° Ø12
• 00887517698223: Monolith Endcap, 22x19mm Lord 7° Ø14
• 00887517698216: Monolith Endcap, 22x19mm Lord 15° Ø14
• 00887517698209: Monolith Endcap, 22x19mm Lord 10° Ø14
• 00887517698087: Monolith Core, Ø14x48mm
• 00887517698070: Monolith Core, Ø14x46mm
• 00887517698063: Monolith Core, Ø14x44mm
• 00887517698056: Monolith Core, Ø14x42mm
• 00887517698049: Monolith Core, Ø14x40mm
• 00887517698032: Monolith Core, Ø14x38mm
• 00887517698025: Monolith Core, Ø14x36mm
• 00887517698018: Monolith Core, Ø14x34mm
• 00887517698001: Monolith Core, Ø14x32mm
• 00887517697998: Monolith Core, Ø14x30mm
• 00887517697981: Monolith Core, Ø14x28mm
• 00887517697974: Monolith Core, Ø14x26mm
• 00887517697967: Monolith Core, Ø14x24mm
• 00887517697950: Monolith Core, Ø14x22mm
• 00887517697943: Monolith Core, Ø12x48mm
• 00887517697936: Monolith Core, Ø12x46mm
• 00887517697929: Monolith Core, Ø12x44mm
• 00887517697912: Monolith Core, Ø12x42mm
• 00887517697905: Monolith Core, Ø12x40mm
• 00887517697899: Monolith Core, Ø12x38mm
• 00887517697882: Monolith Core, Ø12x36mm
• 00887517697875: Monolith Core, Ø12x34mm
• 00887517697868: Monolith Core, Ø12x32mm
• 00887517697851: Monolith Core, Ø12x30mm
• 00887517697844: Monolith Core, Ø12x28mm
• 00887517697837: Monolith Core, Ø12x26mm
• 00887517697820: Monolith Core, Ø12x24mm
• 00887517697813: Monolith Core, Ø12x22mm
• 00887517697806: Monolith Endcap, 22x19mm Parallel Ø14
• 00887517677587: Monolith Removal Tool, Endcap
• 00887517677570: Monolith Tamp
• 00887517677563: Monolith Positioning Tool, Implant
• 00887517677518: Monolith Loading Tool, Graft
• 00887517677471: Monolith Trial, Endcap Ø14/Ø16
• 00887517677464: Monolith Trial, Endcap 17x15/19x16
• 00887517677457: Monolith Trial, Endcap 15x13/17x14