TriLeap Lower Extremity Anatomic Plating System 03.900.369

GUDID 00810112592801

1.6 Sleeve Insert for 2.0 mm Drill Guide

CROSSROADS EXTREMITY SYSTEMS

Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable
Primary Device ID00810112592801
NIH Device Record Keyf47410a6-9a56-4bc0-9c80-309420fb0b54
Commercial Distribution StatusIn Commercial Distribution
Brand NameTriLeap Lower Extremity Anatomic Plating System
Version Model Number1.6 Sleeve Insert for 2.0 mm Drill Guide
Catalog Number03.900.369
Company DUNS058864308
Company NameCROSSROADS EXTREMITY SYSTEMS
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
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
GS100810112592801 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

[00810112592801]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-04
Device Publish Date2024-02-23

On-Brand Devices [TriLeap Lower Extremity Anatomic Plating System]

008101125935632.5 mm Ti Variable Angle Screw Length 32 mm, Magenta
008101125935702.5 mm Ti Variable Angle Screw Length 34 mm, Magenta
008101125957651st MTP Ti Fusion Revision Plate, Medium, 5 Deg, Right
00810112592481Bending Pin for 3.0/3.5/4.0 Plates
008101125958711st & 2nd Ti Lisfranc Joint Fusion Plate, Medium, Left
008101125958641st & 2nd Ti Lisfranc Joint Fusion Plate, Small, Right
008101125958571st & 2nd Ti Lisfranc Joint Fusion Plate, Small, Left
00810112595840Lapidus Ti Plate, Medial, Long
00810112595833Lapidus Ti Plate, Medial, Short
00810112595826Lapidus Ti Plate 4 mm Step, Right
00810112595819Lapidus Ti Plate 4 mm Step, Left
00810112595802Lapidus Ti Plate 2 mm Step, Right
00810112595796Lapidus Ti Plate 2 mm Step, Left
00810112595789Lapidus Ti Plate 0 mm Step, Right
00810112595772Lapidus Ti Plate 0 mm Step, Left
008101125957581st MTP Ti Fusion Revision Plate, Medium, 5 Deg, Left
008101125957411st MTP Ti Fusion Revision Plate, Medium, 0 Deg, Right
008101125957341st MTP Ti Fusion Revision Plate, Medium, 0 Deg, Left
008101125957271st MTP Ti Fusion Revision Plate, Small, 5 Deg, Right
008101125957101st MTP Ti Fusion Revision Plate, Small, 5 Deg, Left
008101125957031st MTP Ti Fusion Revision Plate, Small, 0 Deg, Right
008101125956971st MTP Ti Fusion Revision Plate, Small, 0 Deg, Left
008101125956801st MTP Ti Fusion Plate, Medium, 5 Deg, Right
008101125956731st MTP Ti Fusion Plate, Medium, 5 Deg, Left
008101125956661st MTP Ti Fusion Plate, Medium, 10 Deg, Right
008101125956591st MTP Ti Fusion Plate, Medium, 10 Deg, Left
008101125956421st MTP Ti Fusion Plate, Medium, 0 Deg, Right
008101125956351st MTP Ti Fusion Plate, Medium, 0 Deg, Left
008101125956281st MTP Ti Fusion Plate, Small, 5 Deg, Right
008101125956111st MTP Ti Fusion Plate, Small, 5 Deg, Left
008101125956041st MTP Ti Fusion Plate, Small, 10 Deg, Right
008101125955981st MTP Ti Fusion Plate, Small, 10 Deg, Left
008101125955811st MTP Ti Fusion Plate, Small, 0 Deg, Right
008101125955741st MTP Ti Fusion Plate, Small, 0 Deg, Left
008101125971722.0 Y-Shape Ti Fracture Plate, 6 Hole
008101125971652.0 Y-Shape Ti Fracture Plate, 5 Hole
008101125971582.0 Y-Shape Ti Fracture Plate, 4 Hole
008101125971412.0 Y-Shape Ti Fracture Plate, 3 Hole
008101125971342.0 T-Shape Ti Fracture Plate, 6 Hole
008101125971272.0 T-Shape Ti Fracture Plate, 5 Hole
008101125971102.0 T-Shape Ti Fracture Plate, 4 Hole
008101125971032.0 T-Shape Ti Fracture Plate, 3 Hole
008101125970972.0 Straight Ti Fracture Plate, 8 Hole
008101125970802.0 Straight Ti Fracture Plate, 7 Hole
008101125970732.0 Straight Ti Fracture Plate, 6 Hole
008101125970662.0 Straight Ti Fracture Plate, 5 Hole
008101125970592.0 Straight Ti Fracture Plate, 4 Hole
008101125970422.0 Straight Ti Fracture Plate, 3 Hole
00810112596120Cuboid H Ti Plate, Right
00810112596113Cuboid H Ti Plate, Left
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.