Phantom Hindfoot TTC/TC Nail System P32-450-026F

GUDID 00889795136343

Phantom Nail, Crossing Screw, Ø5.0mm x 26mm length, Headed

PARAGON 28, INC.

Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding)
Primary Device ID00889795136343
NIH Device Record Key5669a478-7089-417d-a2d0-b922649b2229
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhantom Hindfoot TTC/TC Nail System
Version Model NumberP32-450-026F
Catalog NumberP32-450-026F
Company DUNS042961576
Company NamePARAGON 28, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100889795136343 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-15
Device Publish Date2024-04-05

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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