TITAN 3-D Wedge System P03-950-0002

GUDID 00889795020086

TITAN, Evans Precision Screw Guide, Left

PARAGON 28, INC.

Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable
Primary Device ID00889795020086
NIH Device Record Keya9238847-624f-49c7-9dc6-d23c4b07cfe2
Commercial Distribution StatusIn Commercial Distribution
Brand NameTITAN 3-D Wedge System
Version Model NumberP03-950-0002
Catalog NumberP03-950-0002
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
GS100889795020086 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PLFBone Wedge

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889795020086]

Moist Heat or Steam Sterilization


[00889795020086]

Moist Heat or Steam Sterilization


[00889795020086]

Moist Heat or Steam Sterilization


[00889795020086]

Moist Heat or Steam Sterilization


[00889795020086]

Moist Heat or Steam Sterilization


[00889795020086]

Moist Heat or Steam Sterilization


[00889795020086]

Moist Heat or Steam Sterilization


[00889795020086]

Moist Heat or Steam Sterilization


[00889795020086]

Moist Heat or Steam Sterilization


[00889795020086]

Moist Heat or Steam Sterilization


[00889795020086]

Moist Heat or Steam Sterilization


[00889795020086]

Moist Heat or Steam Sterilization


[00889795020086]

Moist Heat or Steam Sterilization


[00889795020086]

Moist Heat or Steam Sterilization


[00889795020086]

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 [TITAN 3-D Wedge System]

00889795020062TITAN, Cotton Resection Guide - Odd Sizes
00889795020055TITAN, Cotton Resection Guide - Even Sizes
00889795020048TITAN, Evans Resection Guide
00889795018236TITAN 3-D Wedge, Cotton, 8mm, Sterile
00889795018229TITAN 3-D Wedge, Cotton, 7mm, Sterile
00889795018212TITAN 3-D Wedge, Cotton, 6mm, Sterile
00889795018205TITAN 3-D Wedge, Cotton, 5mm, Sterile
00889795018199TITAN 3-D Wedge, Evans, Large, 12mm, Sterile
00889795018182TITAN 3-D Wedge, Evans, Large, 10mm, Sterile
00889795018175TITAN 3-D Wedge, Evans, Large, 8mm, Sterile
00889795018168TITAN 3-D Wedge, Evans, Large, 6mm, Sterile
00889795018151TITAN 3-D Wedge, Evans, Small, 12mm, Sterile
00889795018144TITAN 3-D Wedge, Evans, Small, 10mm, Sterile
00889795018137TITAN 3-D Wedge, Evans, Small, 8mm, Sterile
00889795018120TITAN 3-D Wedge, Evans, Small, 6mm, Sterile
00889795050755TRIAL HANDLE, EVANS, 10mm
00889795050748TRIAL HANDLE, COTTON, 6mm
00889795020109TITAN, Cotton Precision Screw Guide, Left
00889795020093TITAN, Cotton Precision Screw Guide, Right
00889795020086TITAN, Evans Precision Screw Guide, Left
00889795020079TITAN, Evans Precision Screw Guide, Right
00889795020031TITAN, Cotton Wedge Inserter
00889795020024TITAN, Evans Wedge Inserter
00889795020017Resection Guide Attachment Hex Handle
00889795020000TITAN Caddy Lid
00889795019981TITAN Instrument Caddy Base
00889795019998TITAN Trial Caddy Base

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.