| Primary Device ID | 00889795098382 | 
| NIH Device Record Key | 69bf949f-0b00-4509-bac3-b821af6ba21c | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Phantom Hindfoot TTC/TC Nail System | 
| Version Model Number | P31-902-RMCD | 
| Catalog Number | P31-902-RMCD | 
| Company DUNS | 042961576 | 
| Company Name | PARAGON 28, INC. | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| 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 Issuing Agency | Device ID | 
|---|---|
| GS1 | 00889795098382 [Primary] | 
| FSM | TRAY, SURGICAL, INSTRUMENT | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
[00889795098382]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2020-12-23 | 
| Device Publish Date | 2020-12-15 | 
| 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 |