SCARLET AL-T INSTRUMENTATION SCA-TM 15 13-N

GUDID 07640185340350

TRIAL MEDIUM

SpineArt SA

Spinal implant trial

• Primary Device ID: 07640185340350
• NIH Device Record Key: 617eb191-8f2a-442e-808a-dcc5e64f3917
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCARLET AL-T INSTRUMENTATION
• Version Model Number: SCA-TM 15 13-N
• Catalog Number: SCA-TM 15 13-N
• Company DUNS: 483016148
• Company Name: SpineArt SA
• 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: true
• 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

• Angle: 15 degree
• Height: 13 Millimeter
• Angle: 15 degree
• Height: 13 Millimeter
• Angle: 15 degree
• Height: 13 Millimeter
• Angle: 15 degree
• Height: 13 Millimeter
• Angle: 15 degree
• Height: 13 Millimeter
• Angle: 15 degree
• Height: 13 Millimeter
• Angle: 15 degree
• Height: 13 Millimeter
• Angle: 15 degree
• Height: 13 Millimeter
• Angle: 15 degree
• Height: 13 Millimeter
• Angle: 15 degree
• Height: 13 Millimeter
• Angle: 15 degree
• Height: 13 Millimeter
• Angle: 15 degree
• Height: 13 Millimeter
• Angle: 15 degree
• Height: 13 Millimeter
• Angle: 15 degree
• Height: 13 Millimeter
• Angle: 15 degree
• Height: 13 Millimeter
• Angle: 15 degree
• Height: 13 Millimeter
• Angle: 15 degree
• Height: 13 Millimeter
• Angle: 15 degree
• Height: 13 Millimeter
• Angle: 15 degree
• Height: 13 Millimeter
• Angle: 15 degree
• Height: 13 Millimeter
• Angle: 15 degree
• Height: 13 Millimeter
• Angle: 15 degree
• Height: 13 Millimeter
• Angle: 15 degree
• Height: 13 Millimeter
• Angle: 15 degree
• Height: 13 Millimeter
• Angle: 15 degree
• Height: 13 Millimeter
• Angle: 15 degree
• Height: 13 Millimeter
• Angle: 15 degree
• Height: 13 Millimeter
• Angle: 15 degree
• Height: 13 Millimeter
• Angle: 15 degree
• Height: 13 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640185340350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181818

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

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

[07640185340350]

Moist Heat or Steam Sterilization

[07640185340350]

Moist Heat or Steam Sterilization

[07640185340350]

Moist Heat or Steam Sterilization

[07640185340350]

Moist Heat or Steam Sterilization

[07640185340350]

Moist Heat or Steam Sterilization

[07640185340350]

Moist Heat or Steam Sterilization

[07640185340350]

Moist Heat or Steam Sterilization

[07640185340350]

Moist Heat or Steam Sterilization

[07640185340350]

Moist Heat or Steam Sterilization

[07640185340350]

Moist Heat or Steam Sterilization

[07640185340350]

Moist Heat or Steam Sterilization

[07640185340350]

Moist Heat or Steam Sterilization

[07640185340350]

Moist Heat or Steam Sterilization

[07640185340350]

Moist Heat or Steam Sterilization

[07640185340350]

Moist Heat or Steam Sterilization

[07640185340350]

Moist Heat or Steam Sterilization

[07640185340350]

Moist Heat or Steam Sterilization

[07640185340350]

Moist Heat or Steam Sterilization

[07640185340350]

Moist Heat or Steam Sterilization

[07640185340350]

Moist Heat or Steam Sterilization

[07640185340350]

Moist Heat or Steam Sterilization

[07640185340350]

Moist Heat or Steam Sterilization

[07640185340350]

Moist Heat or Steam Sterilization

[07640185340350]

Moist Heat or Steam Sterilization

[07640185340350]

Moist Heat or Steam Sterilization

[07640185340350]

Moist Heat or Steam Sterilization

[07640185340350]

Moist Heat or Steam Sterilization

[07640185340350]

Moist Heat or Steam Sterilization

[07640185340350]

Moist Heat or Steam Sterilization

[07640185340350]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2025-03-17
• Device Publish Date: 2018-12-10

On-Brand Devices [SCARLET AL-T INSTRUMENTATION]

• 07640185340596: CUP CURETTE, ANGLED DOWN, SIZE “2”
• 07640185340589: CUP CURETTE, STRAIGHT, SIZE “2”
• 07640185340572: CUP CURETTE, ANGLED DOWN, SIZE “0”
• 07640185340565: CUP CURETTE, STRAIGHT, SIZE “0”
• 07640185340534: STRAIGHT RING CURETTE, 11MM
• 07640185340527: STRAIGHT RING CURETTE, 11MM
• 07640185343344: Cup curette, angled DOWN, size “4”
• 07640185343337: Cup curette, straight, size “4”
• 07640185349018: LATERAL IMPLANT HOLDER LARGE
• 07640185349001: LATERAL IMPLANT HOLDER SMALL/MEDIUM
• 07640185347946: IMPLANT HOLDER LARGE
• 07640185347939: IMPLANT HOLDER SMALL/MEDIUM
• 07640185347922: TRIAL LARGE
• 07640185347915: TRIAL LARGE
• 07640185347908: TRIAL LARGE
• 07640185347892: TRIAL LARGE
• 07640185347885: TRIAL MEDIUM
• 07640185347878: TRIAL MEDIUM
• 07640185347861: TRIAL MEDIUM
• 07640185347854: TRIAL MEDIUM
• 07640185347847: TRIAL SMALL
• 07640185347830: TRIAL SMALL
• 07640185347823: TRIAL SMALL
• 07640185347816: TRIAL SMALL
• 07640185347809: TRIAL LARGE
• 07640185347793: TRIAL LARGE
• 07640185347786: TRIAL LARGE
• 07640185347779: TRIAL LARGE
• 07640185347762: TRIAL LARGE
• 07640185347755: TRIAL LARGE
• 07640185347748: TRIAL LARGE
• 07640185347731: TRIAL LARGE
• 07640185347724: TRIAL MEDIUM
• 07640185347717: TRIAL MEDIUM
• 07640185347700: TRIAL MEDIUM
• 07640185347694: TRIAL MEDIUM
• 07640185347687: TRIAL MEDIUM
• 07640185347670: TRIAL MEDIUM
• 07640185347663: TRIAL MEDIUM
• 07640185347656: TRIAL MEDIUM
• 07640185347649: TRIAL SMALL
• 07640185347632: TRIAL SMALL
• 07640185347625: TRIAL SMALL
• 07640185347618: TRIAL SMALL
• 07640185347601: TRIAL SMALL
• 07640185347595: TRIAL SMALL
• 07640185347588: TRIAL SMALL
• 07640185347571: TRIAL SMALL
• 07640185340855: HUDSON CONNECTOR
• 07640185340848: LATERAL IMPLANT HOLDER SCREW M4X0.7