TrellOss™-A

GUDID 00840067204818

Trial 27Dx36Wx20H 20°

NEXXT SPINE, LLC

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00840067204818
• NIH Device Record Key: 089bddca-a33b-4200-85ce-8bfd3d6fd277
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrellOss™-A
• Version Model Number: 336H2020
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840067204818 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193370

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00840067204818]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-02
• Device Publish Date: 2020-06-24

On-Brand Devices [TrellOss™-A]

• 00840067204467: ALIF Distractor Inserter
• 00840067204849: Implant Remover
• 00840067204832: Slap Hammer Adapter
• 00840067204825: Slap Hammer
• 00840067204863: ALIF Trial Caddy
• 00840067205655: Inline Handle Hudson Conn
• 00840067205303: ALIF 36Wx27Dx20H 20°
• 00840067205297: ALIF 36Wx27Dx18H 20°
• 00840067205280: ALIF 36Wx27Dx16H 20°
• 00840067205273: ALIF 36Wx27Dx14H 20°
• 00840067205266: ALIF 36Wx27Dx12H 20°
• 00840067205259: ALIF 32Wx24Dx20H 20°
• 00840067205242: ALIF 32Wx24Dx18H 20°
• 00840067205235: ALIF 32Wx24Dx16H 20°
• 00840067205228: ALIF 32Wx24Dx14H 20°
• 00840067205211: ALIF 32Wx24Dx12H 20°
• 00840067205204: ALIF 36Wx27Dx20H 14°
• 00840067205198: ALIF 36Wx27Dx18H 14°
• 00840067205181: ALIF 36Wx27Dx16H 14°
• 00840067205174: ALIF 36Wx27Dx14H 14°
• 00840067205167: ALIF 36Wx27Dx12H 14°
• 00840067205150: ALIF 36Wx27Dx10H 14°
• 00840067205143: ALIF 32Wx24Dx20H 14°
• 00840067205136: ALIF 32Wx24Dx18H 14°
• 00840067205129: ALIF 32Wx24Dx16H 14°
• 00840067205112: ALIF 32Wx24Dx14H 14°
• 00840067205105: ALIF 32Wx24Dx12H 14°
• 00840067205099: ALIF 32Wx24Dx10H 14°
• 00840067205082: ALIF 36Wx27Dx20H 8°
• 00840067205075: ALIF 36Wx27Dx18H 8°
• 00840067205068: ALIF 36Wx27Dx16H 8°
• 00840067205051: ALIF 36Wx27Dx14H 8°
• 00840067205044: ALIF 36Wx27Dx12H 8°
• 00840067205037: ALIF 36Wx27Dx10H 8°
• 00840067205020: ALIF 36Wx27Dx8H 8°
• 00840067205013: ALIF 32Wx24Dx20H 8°
• 00840067205006: ALIF 32Wx24Dx18H 8°
• 00840067204993: ALIF 32Wx24Dx16H 8°
• 00840067204986: ALIF 32Wx24Dx14H 8°
• 00840067204979: ALIF 32Wx24Dx12H 8°
• 00840067204962: ALIF 32Wx24Dx10H 8°
• 00840067204955: ALIF 32Wx24Dx8H 8°
• 00840067204870: ALIF Implant Inserter
• 00840067204818: Trial 27Dx36Wx20H 20°
• 00840067204801: Trial 27Dx36Wx18H 20°
• 00840067204795: Trial 27Dx36Wx16H 20°
• 00840067204788: Trial 27Dx36Wx14H 20°
• 00840067204771: Trial 27Dx36Wx12H 20°
• 00840067204764: Trial 27Dx36Wx20H 14°
• 00840067204757: Trial 27Dx36Wx18H 14°