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

GUDID 00889795110824

Proximal Arm Assembly

PARAGON 28, INC.

Orthopaedic implantation sleeve, reusable
Primary Device ID00889795110824
NIH Device Record Keyfd9eda75-9bc7-4b5f-90a7-15212113f46e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhantom Hindfoot TTC/TC Nail System
Version Model NumberP31-950-0035
Catalog NumberP31-950-0035
Company DUNS042961576
Company NamePARAGON 28, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100889795110824 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-23
Device Publish Date2020-12-15

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

00889795110824Proximal Arm Assembly
00889795098382Phantom Hindfoot TTC/TC Nail, Reamer Caddy, Case 2 of 3
00889795098375Phantom Hindfoot TTC/TC Nail, Tray 2, Case 2 of 3
00889795098368Phantom Hindfoot TTC/TC Nail, Tray 1, Case 2 of 3
00889795098351Phantom Hindfoot TTC/TC Nail, Case Base, Case 2 of 3
00889795098344Phantom Hindfoot TTC/TC Nail, Caddy 2 Base, Case 3 of 3
00889795098337Phantom Hindfoot TTC/TC Nail, Caddy 2 Lid, Case 3 of 3
00889795098320Phantom Hindfoot TTC/TC Nail, Caddy 1 Base, Case 3 of 3
00889795098313Phantom Hindfoot TTC/TC Nail, Caddy 1 Lid, Case 3 of 3
00889795098306Phantom Hindfoot TTC/TC Nail, Tray 2, Case 3 of 3
00889795098290Phantom Hindfoot TTC/TC Nail, Tray 1, Case 3 of 3
00889795098283Phantom Hindfoot TTC/TC Nail, Case Base, Case 3 of 3
00889795098276Phantom Hindfoot Nail, Compression End Cap, Long
00889795098269Phantom Hindfoot Nail, Compression End Cap, Short
00889795098252Phantom Hindfoot Nail, Shouldered End Cap, Long
00889795098245Phantom Hindfoot Nail, Shouldered End Cap, Short
00889795098238Phantom Hindfoot Nail, Internal Compression Screw
00889795098221Phantom Nail, Crossing Screw, Ø5.0mm x 70mm length, Headed
00889795098214Phantom Nail, Crossing Screw, Ø5.0mm x 68mm length, Headed
00889795098207Phantom Nail, Crossing Screw, Ø5.0mm x 66mm length, Headed
00889795098191Phantom Nail, Crossing Screw, Ø5.0mm x 64mm length, Headed
00889795098184Phantom Nail, Crossing Screw, Ø5.0mm x 62mm length, Headed
00889795098177Phantom Nail, Calcaneus Screw, Ø7.2mm x 55mm length, Headless
00889795098160Phantom Nail, Calcaneus Screw, Ø7.2mm x 50mm length, Headless
00889795098153Phantom Nail, Calcaneus Screw, Ø7.2mm x 45mm length, Headless
00889795098146Phantom Screw Driver Attachment, Cannulated, 3/16" Sq. Connection, TX-30 x 85mm
00889795098139Screw Driver Attachment, Solid, 3/16" Sq. Connection, TX-20 x 160mm
00889795098122Phantom Hindfoot Depth Gauge, Cannulated
00889795098115Phantom Hindfoot Depth Gauge, Solid
00889795098108Drill, 3.8 X 250mm Drill, Solid, Trocar Tip, 3/16" Sq. Connection
00889795098092Explant Attachment, Phantom Hindfoot
00889795098085Bolt Driver Attachment, 8mm Hex, Phantom Hindfoot
00889795098078Ghost Outrigger Homerun Guidewire Sleeve, 7.0mm
00889795098061Ghost Outrigger Homerun Guidewire Sleeve, 5.5mm
00889795098054Ghost Outrigger Homerun Guidewire Sleeve, 4.0mm
00889795098047Ghost Outrigger Guide, Homerun Screw Arm
00889795098030Ghost Outrigger Guide, Subtalar Arm
00889795098023Ghost Outrigger Calc Screw Guide, 7.2mm
00889795098016Ghost Outrigger Subtalar Screw Guide, 7.2mm
00889795098009Ghost Outrigger Subtalar Drill Guide, 7.2mm
00889795097996Ghost Outrigger Calc Screw Guide, 7.2mm, Active
00889795097989Phantom Hindfoot Flexible Reamer Shaft, 345mm
00889795097972Phantom Hindfoot Ball Tipped Guide Rod, 3.0 x 550mm
00889795097965Phantom Hindfoot TTC/TC Nail, Tray 2, Case 1 of 3
00889795097958Phantom Hindfoot TTC/TC Nail, Tray 1, Case 1 of 3
00889795097941Phantom Hindfoot TTC/TC Nail, Case Base, Case 1 of 3
00889795097934Phantom Hindfoot TTC/TC Nail, Case Lid
00889795097927Tissue Protector
008897950979107.0 x 20cm Drill
00889795097903PRECISION® Parallel Offset Guide

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