Tranquil-L™

GUDID B7688220310

9mm Lumbar Shaver Distractor

NEXUS SPINE, L.L.C.

Metallic spinal interbody fusion cage

• Primary Device ID: B7688220310
• NIH Device Record Key: 1638b2bc-5b02-489b-ac8f-0999cb935293
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tranquil-L™
• Version Model Number: 822031
• 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: 9 Millimeter
• Width: 9 Millimeter
• Width: 9 Millimeter
• Width: 9 Millimeter
• Width: 9 Millimeter
• Width: 9 Millimeter
• Width: 9 Millimeter
• Width: 9 Millimeter
• Width: 9 Millimeter
• Width: 9 Millimeter
• Width: 9 Millimeter
• Width: 9 Millimeter
• Width: 9 Millimeter
• Width: 9 Millimeter
• Width: 9 Millimeter
• Width: 9 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B7688220310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170297

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[B7688220310]

Moist Heat or Steam Sterilization

[B7688220310]

Moist Heat or Steam Sterilization

[B7688220310]

Moist Heat or Steam Sterilization

[B7688220310]

Moist Heat or Steam Sterilization

[B7688220310]

Moist Heat or Steam Sterilization

[B7688220310]

Moist Heat or Steam Sterilization

[B7688220310]

Moist Heat or Steam Sterilization

[B7688220310]

Moist Heat or Steam Sterilization

[B7688220310]

Moist Heat or Steam Sterilization

[B7688220310]

Moist Heat or Steam Sterilization

[B7688220310]

Moist Heat or Steam Sterilization

[B7688220310]

Moist Heat or Steam Sterilization

[B7688220310]

Moist Heat or Steam Sterilization

[B7688220310]

Moist Heat or Steam Sterilization

[B7688220310]

Moist Heat or Steam Sterilization

[B7688220310]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-08
• Device Publish Date: 2022-02-28

On-Brand Devices [Tranquil-L™]

• B6788232070: DLIF Trial 16x26mm, 12 deg
• B6788232060: DLIF Trial 14x26mm, 12 deg
• B6788232050: DLIF Trial 12x26mm, 12 deg
• B6788232040: DLIF Trial 10x26mm, 12 deg
• B6788232030: DLIF Trial 8x26mm, 12 deg
• B6788232020: DLIF Trial 16x22mm, 12 deg
• B6788232010: DLIF Trial 14x22mm, 12 deg
• B6788232000: DLIF Trial 12x22mm, 12 deg
• B6788231990: DLIF Trial 10x22mm, 12 deg
• B6788231980: DLIF Trial 8x22mm, 12 deg
• B6788231970: DLIF Trial 16x18mm, 12 deg
• B6788231960: DLIF Trial 14x18mm, 12 deg
• B6788231950: DLIF Trial 12x18mm, 12 deg
• B6788231940: DLIF Trial 10x18mm, 12 deg
• B6788231930: DLIF Trial 8x18mm, 12 deg
• B6788231920: DLIF Trial 16x26mm, 6 deg
• B6788231910: DLIF Trial 14x26mm, 6 deg
• B6788231900: DLIF Trial 12x26mm, 6 deg
• B6788231890: DLIF Trial 10x26mm, 6 deg
• B6788231880: DLIF Trial 8x26mm, 6 deg
• B6788231870: DLIF Trial 16x22mm, 6 deg
• B6788231860: DLIF Trial 14x22mm, 6 deg
• B6788231850: DLIF Trial 12x22mm, 6 deg
• B6788231840: DLIF Trial 10x22mm, 6 deg
• B6788231830: DLIF Trial 8x22mm, 6 deg
• B6788231820: DLIF Trial 16x18mm, 6 deg
• B6788231810: DLIF Trial 14x18mm, 6 deg
• B6788231800: DLIF Trial 12x18mm, 6 deg
• B6788231790: DLIF Trial 10x18mm, 6 deg
• B6788231780: DLIF Trial 8x18mm, 6 deg
• B6788231710: Tranquil-L DLIF Rescue Inserter Claw
• B6788231680: Tranquil-L DLIF Rescue Inserter
• B6788231670: Tranquil-L DLIF Inserter
• B6788231600: DLIF Rasp 16x18mm
• B6788231590: DLIF Rasp 14x18mm
• B6788231580: DLIF Rasp 12x18mm
• B6788231570: DLIF Rasp 10x18mm
• B6788231560: DLIF Rasp 8x18mm
• B6788231550: DLIF Rasp 6x18mm
• B6788230910: 17mm - Trial Distractor, 18 Deg
• B6788230900: 16mm - Trial Distractor, 18 Deg
• B6788230890: 15mm - Trial Distractor, 18 Deg
• B6788230880: 14mm - Trial Distractor, 18 Deg
• B6788230870: 13mm - Trial Distractor, 18 Deg
• B6788230860: 12mm - Trial Distractor, 18 Deg
• B6788230850: 17mm - Trial Distractor, 12 Deg
• B6788230840: 16mm - Trial Distractor, 12 Deg
• B6788230830: 15mm - Trial Distractor, 12 Deg
• B6788230820: 14mm - Trial Distractor, 12 Deg
• B6788230810: 13mm - Trial Distractor, 12 Deg