Phantom® Fibula Nail System P36-920-6816

GUDID 00889795134660

6.8mm Distal Reamer, Cannulated, AO Quick Connect

PARAGON 28, INC.

Bone-resection orthopaedic reamer, single-use

• Primary Device ID: 00889795134660
• NIH Device Record Key: 454eea50-317a-4a0a-981f-ff87bab4db03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Phantom® Fibula Nail System
• Version Model Number: P36-920-6816
• Catalog Number: P36-920-6816
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• 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: false
• Expiration Date: true
• 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	00889795134660 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K234128

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-02
• Device Publish Date: 2024-09-24

On-Brand Devices [Phantom® Fibula Nail System]

• 00889795141248: Removal Hook, Pin
• 00889795137234: Bone Hook, Large Handle
• 00889795137180: 1.6mm x 70mm, Sterilization K-Wire Container
• 00889795137159: 2.3mm x 230mm, Sterilization K-Wire Container
• 00889795137135: 2.0mm x 150mm, Sterilization K-Wire Container
• 00889795137128: 1.6mm x 230mm, Sterilization K-Wire Container
• 00889795137111: Removal Hook, Body
• 00889795137104: 4.0mm Single Lead Tap, AO Quick Connect
• 00889795137098: Screw Countersink, AO Quick Connect
• 00889795137081: 3.2mm R3ACT Drill Bit, 17mm Calibrated, AO Quick Connect
• 00889795137074: 3.2mm R3ACT Drill Bit, 14mm Calibrated, AO Quick Connect
• 00889795137067: 2.5mm Drill Bit, Calibrated, AO Quick Connect
• 00889795137050: 6.5mm Proximal Reamer, Solid, AO Quick Connect
• 00889795137043: 6.0mm Proximal Reamer, Solid, AO Quick Connect
• 00889795137036: 5.2mm Proximal Reamer, Solid, AO Quick Connect
• 00889795137029: 4.5mm Proximal Reamer, Solid, AO Quick Connect
• 00889795137012: 3.9mm Proximal Reamer, Solid, AO Quick Connect
• 00889795137005: 3.3mm Proximal Reamer, Solid, AO Quick Connect
• 00889795136992: 2.6mm Proximal Reamer, Solid, AO Quick Connect
• 00889795136961: 2.0mm x 150mm, Trocar K-Wire
• 00889795136954: 1.6mm x 230mm, Entry Guidewire, Trocar
• 00889795135094: Phantom Fibula Nail System, Screw Caddy Lid
• 00889795135087: Phantom Fibula Nail System, Screw Caddy Base
• 00889795135070: Phantom Fibula Nail System, Case 1 of 1, Instrument Tray 2
• 00889795135063: Phantom Fibula Nail System, Case 1 of 1, Instrument Tray 1
• 00889795135056: Phantom Fibula Nail System, Case 1 of 1, Case Lid
• 00889795135049: Phantom Fibula Nail System, Case 1 of 1, Case Base
• 00889795135018: Easy-Out Removal Tool, Small, AO Quick Connect
• 00889795135001: Small Mallet
• 00889795134998: Impaction Attachment
• 00889795134981: T25 Hexalobe Driver, AO Quick Connect
• 00889795134974: T10 Hexalobe Driver, Calibrated, AO Quick Connect
• 00889795134950: Probe Depth Gauge
• 00889795134936: Nail Template
• 00889795134929: R3FLEX Step Drill Bit, Calibrated, AO Quick Connect
• 00889795134905: 2.8mm Drill Bit, Calibrated, AO Quick Connect
• 00889795134875: Dynamic Screw Sleeve
• 00889795134868: Dynamic Drill Sleeve
• 00889795134851: 3.5mm Center Screw Sleeve
• 00889795134844: 3.5mm Screw Sleeve
• 00889795134837: 2.5mm Drill Sleeve
• 00889795134820: 2.7mm Screw Sleeve
• 00889795134813: 2.0mm Drill Sleeve
• 00889795134806: K-Wire Clamp Sleeve
• 00889795134790: Curved K-Wire Reduction Sleeve, Non-Targeting
• 00889795134783: Curved K-Wire Reduction Sleeve, Targeting
• 00889795134776: Targeter Knob
• 00889795134769: Outrigger Attachment Bolt
• 00889795134752: Outrigger Targeter
• 00889795134745: Outrigger Base