Advanced Research Medical Trident SI Screw System 03-65-13

GUDID 00840239800077

Ø13 mm X 65 mm Trident Screw

ADVANCED RESEARCH MEDICAL LLC

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile

• Primary Device ID: 00840239800077
• NIH Device Record Key: 4076d9bc-12ca-4026-b33a-7a3e6f8506a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advanced Research Medical Trident SI Screw System
• Version Model Number: 03-65-13
• Catalog Number: 03-65-13
• Company DUNS: 117201206
• Company Name: ADVANCED RESEARCH MEDICAL 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: true
• 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

Customer Support Contacts

• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com
• Phone: 6124401865
• Email: info@advresmed.com

Device Dimensions

• Outer Diameter: 13 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 13 Millimeter
• Length: 65 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840239800077 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203373

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

[00840239800077]

Moist Heat or Steam Sterilization

[00840239800077]

Moist Heat or Steam Sterilization

[00840239800077]

Moist Heat or Steam Sterilization

[00840239800077]

Moist Heat or Steam Sterilization

[00840239800077]

Moist Heat or Steam Sterilization

[00840239800077]

Moist Heat or Steam Sterilization

[00840239800077]

Moist Heat or Steam Sterilization

[00840239800077]

Moist Heat or Steam Sterilization

[00840239800077]

Moist Heat or Steam Sterilization

[00840239800077]

Moist Heat or Steam Sterilization

[00840239800077]

Moist Heat or Steam Sterilization

[00840239800077]

Moist Heat or Steam Sterilization

[00840239800077]

Moist Heat or Steam Sterilization

[00840239800077]

Moist Heat or Steam Sterilization

[00840239800077]

Moist Heat or Steam Sterilization

[00840239800077]

Moist Heat or Steam Sterilization

[00840239800077]

Moist Heat or Steam Sterilization

[00840239800077]

Moist Heat or Steam Sterilization

[00840239800077]

Moist Heat or Steam Sterilization

[00840239800077]

Moist Heat or Steam Sterilization

[00840239800077]

Moist Heat or Steam Sterilization

[00840239800077]

Moist Heat or Steam Sterilization

[00840239800077]

Moist Heat or Steam Sterilization

[00840239800077]

Moist Heat or Steam Sterilization

[00840239800077]

Moist Heat or Steam Sterilization

[00840239800077]

Moist Heat or Steam Sterilization

[00840239800077]

Moist Heat or Steam Sterilization

[00840239800077]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-20
• Device Publish Date: 2021-04-12

On-Brand Devices [Advanced Research Medical Trident SI Screw System]

• 00840239800213: Handle
• 00840239800008: Ø13 mm X 30 mm Trident Screw
• 00840239800367: 1/4" Square Quick Connect Palm Handle
• 00840239800350: Trident Case Assembly
• 00840239800343: Trident Optional Screw Caddy and Lid
• 00840239800336: Trident Primary Screw Caddy and Lid
• 00840239800329: Insulating Sleeve
• 00840239800312: Dilator - 22mm
• 00840239800305: Dilator - 8mm
• 00840239800299: Graft Tamp
• 00840239800282: Graft Delivery Sleeve
• 00840239800275: Side Screw Driver [Non-Retaining]
• 00840239800268: Side Screw Driver [Self-Retaining]
• 00840239800251: Removal Sleeve
• 00840239800244: Introducer Sleeve
• 00840239800237: Square Driver
• 00840239800220: Guide Wire
• 00840239800206: Ø6 mm X 65 mm Trident Screw
• 00840239800190: Ø6 mm X 60 mm Trident Screw
• 00840239800183: Ø6 mm X 55 mm Trident Screw
• 00840239800176: Ø6 mm X 50 mm Trident Screw
• 00840239800169: Ø6 mm X 45 mm Trident Screw
• 00840239800152: Ø6 mm X 40 mm Trident Screw
• 00840239800145: Ø6 mm X 35 mm Trident Screw
• 00840239800138: Ø6 mm X 30 mm Trident Screw
• 00840239800121: Ø13 mm X 90 mm Trident Screw
• 00840239800114: Ø13 mm X 85 mm Trident Screw
• 00840239800107: Ø13 mm X 80 mm Trident Screw
• 00840239800091: Ø13 mm X 75 mm Trident Screw
• 00840239800084: Ø13 mm X 70 mm Trident Screw
• 00840239800077: Ø13 mm X 65 mm Trident Screw
• 00840239800060: Ø13 mm X 60 mm Trident Screw
• 00840239800053: Ø13 mm X 55 mm Trident Screw
• 00840239800046: Ø13 mm X 50 mm Trident Screw
• 00840239800039: Ø13 mm X 45 mm Trident Screw
• 00840239800022: Ø13 mm X 40 mm Trident Screw
• 00840239800015: Ø13 mm X 35 mm Trident Screw
• 00840239800374: Measuring Sleeve
• 00840239800381: 1/4" Square Quick Connect Ratcheting Tee Cannulated Handle
• 00840239800442: Awl
• 00840239800633: 8mm Cannulated Drill
• 00840239800879: Trident Instrument Platform
• 00840239800862: Trident Primary Screw Caddy and Lid
• 00840239800855: Trident Basket