| 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
| 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 |