Tranquil-C™

GUDID B6788224710

Cervical Rasp +DS 8x12x12

NEXUS SPINE, L.L.C.

Metallic spinal interbody fusion cage

• Primary Device ID: B6788224710
• NIH Device Record Key: 7e222dd4-8a58-4bc4-a8d0-b24605582edd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tranquil-C™
• Version Model Number: 822471
• Company DUNS: 028137605
• Company Name: NEXUS SPINE, L.L.C.
• 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

Device Dimensions

• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B678822471 [Direct Marking]
HIBCC	B6788224710 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170297

FDA Product Code

• HTR: Rasp
• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

[B6788224710]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-27
• Device Publish Date: 2021-12-17

On-Brand Devices [Tranquil-C™]

• B6788230480: Stable-C Inserter
• B6788227110: Cervical Rasp, Thin Shaft, 10x18x14, 6 deg
• B6788227100: Cervical Rasp, Thin Shaft, 9x18x14, 6 deg
• B6788227090: Cervical Rasp, Thin Shaft, 8x18x14, 6 deg
• B6788227080: Cervical Rasp, Thin Shaft, 7x18x14, 6 deg
• B6788227070: Cervical Rasp, Thin Shaft, 6x18x14, 6 deg
• B6788227060: Cervical Rasp, Thin Shaft, 5x18x14, 6 deg
• B6788227030: Cervical Rasp, Thin Shaft, 10x16x13, 6 deg
• B6788227020: Cervical Rasp, Thin Shaft, 9x16x13, 6 deg
• B6788227010: Cervical Rasp, Thin Shaft, 8x16x13, 6 deg
• B6788227000: Cervical Rasp, Thin Shaft, 7x16x13, 6 deg
• B6788226990: Cervical Rasp, Thin Shaft, 6x16x13, 6 deg
• B6788226980: Cervical Rasp, Thin Shaft, 5x16x13, 6 deg
• B6788226950: Cervical Rasp, Thin Shaft, 10x14x12, 6 deg
• B6788226940: Cervical Rasp, Thin Shaft, 9x14x12, 6 deg
• B6788226930: Cervical Rasp, Thin Shaft, 8x14x12, 6 deg
• B6788226920: Cervical Rasp, Thin Shaft, 7x14x12, 6 deg
• B6788226910: Cervical Rasp, Thin Shaft, 6x14x12, 6 deg
• B6788226900: Cervical Rasp, Thin Shaft, 5x14x12, 6 deg
• B6788226470: Cervical Trial, Thin Shaft, 10x18x14, 6 deg
• B6788226460: Cervical Trial, Thin Shaft, 9x18x14, 6 deg
• B6788226450: Cervical Trial, Thin Shaft, 8x18x14, 6 deg
• B6788226440: Cervical Trial, Thin Shaft, 7x18x14, 6 deg
• B6788226430: Cervical Trial, Thin Shaft, 6x18x14, 6 deg
• B6788226420: Cervical Trial, Thin Shaft, 5x18x14, 6 deg
• B6788226390: Cervical Trial, Thin Shaft, 10x16x13, 6 deg
• B6788226380: Cervical Trial, Thin Shaft, 9x16x13, 6 deg
• B6788226370: Cervical Trial, Thin Shaft, 8x16x13, 6 deg
• B6788226360: Cervical Trial, Thin Shaft, 7x16x13, 6 deg
• B6788226350: Cervical Trial, Thin Shaft, 6x16x13, 6 deg
• B6788226340: Cervical Trial, Thin Shaft, 5x16x13, 6 deg
• B6788226310: Cervical Trial, Thin Shaft, 10x14x12, 6 deg
• B6788226300: Cervical Trial, Thin Shaft, 9x14x12, 6 deg
• B6788226290: Cervical Trial, Thin Shaft, 8x14x12, 6 deg
• B6788226280: Cervical Trial, Thin Shaft, 7x14x12, 6 deg
• B6788226270: Cervical Trial, Thin Shaft, 6x14x12, 6 deg
• B6788226260: Cervical Trial, Thin Shaft, 5x14x12, 6 deg
• B6788225470: Cervical Rasp 12x18x14, 12 deg Lordotic
• B6788225460: Cervical Rasp 11x18x14, 12 deg Lordotic
• B6788225450: Cervical Rasp 10x18x14, 12 deg Lordotic
• B6788225440: Cervical Rasp 9x18x14, 12 deg Lordotic
• B6788225430: Cervical Rasp 8x18x14, 12 deg Lordotic
• B6788225420: Cervical Rasp 7x18x14, 12 deg Lordotic
• B6788225410: Cervical Rasp 6x18x14, 12 deg Lordotic
• B6788225400: Cervical Rasp 5x18x14, 12 deg Lordotic
• B6788225390: Cervical Rasp 12x16x13, 12 deg Lordotic
• B6788225380: Cervical Rasp 11x16x13, 12 deg Lordotic
• B6788225370: Cervical Rasp 10x16x13, 12 deg Lordotic
• B6788225360: Cervical Rasp 9x16x13, 12 deg Lordotic
• B6788225350: Cervical Rasp 8x16x13, 12 deg Lordotic