Phantom Hindfoot TTC/TC Nail System P31-950-0035

GUDID 00889795110824

Proximal Arm Assembly

PARAGON 28, INC.

Orthopaedic implantation sleeve, reusable

• Primary Device ID: 00889795110824
• NIH Device Record Key: fd9eda75-9bc7-4b5f-90a7-15212113f46e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Phantom Hindfoot TTC/TC Nail System
• Version Model Number: P31-950-0035
• Catalog Number: P31-950-0035
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00889795110824 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201227

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

[00889795110824]

Moist Heat or Steam Sterilization

[00889795110824]

Moist Heat or Steam Sterilization

[00889795110824]

Moist Heat or Steam Sterilization

[00889795110824]

Moist Heat or Steam Sterilization

[00889795110824]

Moist Heat or Steam Sterilization

[00889795110824]

Moist Heat or Steam Sterilization

[00889795110824]

Moist Heat or Steam Sterilization

[00889795110824]

Moist Heat or Steam Sterilization

[00889795110824]

Moist Heat or Steam Sterilization

[00889795110824]

Moist Heat or Steam Sterilization

[00889795110824]

Moist Heat or Steam Sterilization

[00889795110824]

Moist Heat or Steam Sterilization

[00889795110824]

Moist Heat or Steam Sterilization

[00889795110824]

Moist Heat or Steam Sterilization

[00889795110824]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-23
• Device Publish Date: 2020-12-15

On-Brand Devices [Phantom Hindfoot TTC/TC Nail System]

• 00889795110824: Proximal Arm Assembly
• 00889795098382: Phantom Hindfoot TTC/TC Nail, Reamer Caddy, Case 2 of 3
• 00889795098375: Phantom Hindfoot TTC/TC Nail, Tray 2, Case 2 of 3
• 00889795098368: Phantom Hindfoot TTC/TC Nail, Tray 1, Case 2 of 3
• 00889795098351: Phantom Hindfoot TTC/TC Nail, Case Base, Case 2 of 3
• 00889795098344: Phantom Hindfoot TTC/TC Nail, Caddy 2 Base, Case 3 of 3
• 00889795098337: Phantom Hindfoot TTC/TC Nail, Caddy 2 Lid, Case 3 of 3
• 00889795098320: Phantom Hindfoot TTC/TC Nail, Caddy 1 Base, Case 3 of 3
• 00889795098313: Phantom Hindfoot TTC/TC Nail, Caddy 1 Lid, Case 3 of 3
• 00889795098306: Phantom Hindfoot TTC/TC Nail, Tray 2, Case 3 of 3
• 00889795098290: Phantom Hindfoot TTC/TC Nail, Tray 1, Case 3 of 3
• 00889795098283: Phantom Hindfoot TTC/TC Nail, Case Base, Case 3 of 3
• 00889795098276: Phantom Hindfoot Nail, Compression End Cap, Long
• 00889795098269: Phantom Hindfoot Nail, Compression End Cap, Short
• 00889795098252: Phantom Hindfoot Nail, Shouldered End Cap, Long
• 00889795098245: Phantom Hindfoot Nail, Shouldered End Cap, Short
• 00889795098238: Phantom Hindfoot Nail, Internal Compression Screw
• 00889795098221: Phantom Nail, Crossing Screw, Ø5.0mm x 70mm length, Headed
• 00889795098214: Phantom Nail, Crossing Screw, Ø5.0mm x 68mm length, Headed
• 00889795098207: Phantom Nail, Crossing Screw, Ø5.0mm x 66mm length, Headed
• 00889795098191: Phantom Nail, Crossing Screw, Ø5.0mm x 64mm length, Headed
• 00889795098184: Phantom Nail, Crossing Screw, Ø5.0mm x 62mm length, Headed
• 00889795098177: Phantom Nail, Calcaneus Screw, Ø7.2mm x 55mm length, Headless
• 00889795098160: Phantom Nail, Calcaneus Screw, Ø7.2mm x 50mm length, Headless
• 00889795098153: Phantom Nail, Calcaneus Screw, Ø7.2mm x 45mm length, Headless
• 00889795098146: Phantom Screw Driver Attachment, Cannulated, 3/16" Sq. Connection, TX-30 x 85mm
• 00889795098139: Screw Driver Attachment, Solid, 3/16" Sq. Connection, TX-20 x 160mm
• 00889795098122: Phantom Hindfoot Depth Gauge, Cannulated
• 00889795098115: Phantom Hindfoot Depth Gauge, Solid
• 00889795098108: Drill, 3.8 X 250mm Drill, Solid, Trocar Tip, 3/16" Sq. Connection
• 00889795098092: Explant Attachment, Phantom Hindfoot
• 00889795098085: Bolt Driver Attachment, 8mm Hex, Phantom Hindfoot
• 00889795098078: Ghost Outrigger Homerun Guidewire Sleeve, 7.0mm
• 00889795098061: Ghost Outrigger Homerun Guidewire Sleeve, 5.5mm
• 00889795098054: Ghost Outrigger Homerun Guidewire Sleeve, 4.0mm
• 00889795098047: Ghost Outrigger Guide, Homerun Screw Arm
• 00889795098030: Ghost Outrigger Guide, Subtalar Arm
• 00889795098023: Ghost Outrigger Calc Screw Guide, 7.2mm
• 00889795098016: Ghost Outrigger Subtalar Screw Guide, 7.2mm
• 00889795098009: Ghost Outrigger Subtalar Drill Guide, 7.2mm
• 00889795097996: Ghost Outrigger Calc Screw Guide, 7.2mm, Active
• 00889795097989: Phantom Hindfoot Flexible Reamer Shaft, 345mm
• 00889795097972: Phantom Hindfoot Ball Tipped Guide Rod, 3.0 x 550mm
• 00889795097965: Phantom Hindfoot TTC/TC Nail, Tray 2, Case 1 of 3
• 00889795097958: Phantom Hindfoot TTC/TC Nail, Tray 1, Case 1 of 3
• 00889795097941: Phantom Hindfoot TTC/TC Nail, Case Base, Case 1 of 3
• 00889795097934: Phantom Hindfoot TTC/TC Nail, Case Lid
• 00889795097927: Tissue Protector
• 00889795097910: 7.0 x 20cm Drill
• 00889795097903: PRECISION® Parallel Offset Guide