TrellOss™-C SA

GUDID 00840067206386

Guide Head 7mm

NEXXT SPINE, LLC

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00840067206386
• NIH Device Record Key: 70252e9c-e1d5-41aa-8f57-191fb6e3ca9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrellOss™-C SA
• Version Model Number: 137N1207
• Company DUNS: 003489810
• Company Name: NEXXT SPINE, LLC
• 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: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840067206386 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200543

FDA Product Code

• OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

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

[00840067206386]

Moist Heat or Steam Sterilization

[00840067206386]

Moist Heat or Steam Sterilization

[00840067206386]

Moist Heat or Steam Sterilization

[00840067206386]

Moist Heat or Steam Sterilization

[00840067206386]

Moist Heat or Steam Sterilization

[00840067206386]

Moist Heat or Steam Sterilization

[00840067206386]

Moist Heat or Steam Sterilization

[00840067206386]

Moist Heat or Steam Sterilization

[00840067206386]

Moist Heat or Steam Sterilization

[00840067206386]

Moist Heat or Steam Sterilization

[00840067206386]

Moist Heat or Steam Sterilization

[00840067206386]

Moist Heat or Steam Sterilization

[00840067206386]

Moist Heat or Steam Sterilization

[00840067206386]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-29
• Device Publish Date: 2020-07-21

On-Brand Devices [TrellOss™-C SA]

• 00840067205334: TrellOss™-C SA Straight Driver
• 00840067205327: TrellOss™-C SA Straight Drill
• 00840067205310: Lock Tool
• 00840067205976: Ø4.0x18mm Screw, Self Tapping
• 00840067205969: Ø4.0x16mm Screw, Self Tapping
• 00840067205952: Ø4.0x14mm Screw, Self Tapping
• 00840067205945: Ø4.0x12mm Screw, Self Tapping
• 00840067205938: Ø3.5x18mm Screw, Self Tapping
• 00840067205921: Ø3.5x16mm Screw, Self Tapping
• 00840067205914: Ø3.5x14mm Screw, Self Tapping
• 00840067205907: Ø3.5x12mm Screw, Self Tapping
• 00840067205891: TrellOss-C SA 16Dx18Wx12H 6°
• 00840067205884: TrellOss-C SA 16Dx18Wx11H 6°
• 00840067205877: TrellOss-C SA 16Dx18Wx10H 6°
• 00840067205860: TrellOss-C SA 16Dx18Wx9H 6°
• 00840067205853: TrellOss-C SA 16Dx18Wx8H 6°
• 00840067205846: TrellOss-C SA 16Dx18Wx7H 6°
• 00840067205839: TrellOss-C SA 16Dx18Wx6H 6°
• 00840067205822: TrellOss-C SA 16Dx18Wx5H 6°
• 00840067205815: TrellOss-C SA 14Dx16Wx12H 6°
• 00840067205808: TrellOss-C SA 14Dx16Wx11H 6°
• 00840067205792: TrellOss-C SA 14Dx16Wx10H 6°
• 00840067205785: TrellOss-C SA 14Dx16Wx9H 6°
• 00840067205778: TrellOss-C SA 14Dx16Wx8H 6°
• 00840067205761: TrellOss-C SA 14Dx16Wx7H 6°
• 00840067205754: TrellOss-C SA 14Dx16Wx6H 6°
• 00840067205747: TrellOss-C SA 14Dx16Wx5H 6°
• 00840067205730: TrellOss-C SA 12Dx15Wx12H 6°
• 00840067205723: TrellOss-C SA 12Dx15Wx11H 6°
• 00840067205716: TrellOss-C SA 12Dx15Wx10H 6°
• 00840067205709: TrellOss-C SA 12Dx15Wx9H 6°
• 00840067205693: TrellOss-C SA 12Dx15Wx8H 6°
• 00840067205686: TrellOss-C SA 12Dx15Wx7H 6°
• 00840067205679: TrellOss-C SA 12Dx15Wx6H 6°
• 00840067205662: TrellOss-C SA 12Dx15Wx5H 6°
• 00840067206218: Rasp 16x18x12mm 6°
• 00840067206201: Rasp 16x18x11mm 6°
• 00840067206195: Rasp 16x18x10mm 6°
• 00840067206188: Rasp 16x18x9mm 6°
• 00840067206171: Rasp 16x18x8mm 6°
• 00840067206164: Rasp 16x18x7mm 6°
• 00840067206157: Rasp 16x18x6mm 6°
• 00840067206140: Rasp 16x18x5mm 6°
• 00840067206133: Rasp 14x16x12mm 6°
• 00840067206126: Rasp 14x16x11mm 6°
• 00840067206119: Rasp 14x16x10mm 6°
• 00840067206102: Rasp 14x16x9mm 6°
• 00840067206096: Rasp 14x16x8mm 6°
• 00840067206089: Rasp 14x16x7mm 6°
• 00840067206072: Rasp 14x16x6mm 6°