TriLeap Lower Etremity Anatomic Plating System 60.900.307

GUDID 00810112592467

Implant Module for Midfoot Fusion Plates

CROSSROADS EXTREMITY SYSTEMS

Surgical instrument/implant rack
Primary Device ID00810112592467
NIH Device Record Keyb5f9d4e0-785d-4994-8b9c-a47234427b5c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTriLeap Lower Etremity Anatomic Plating System
Version Model NumberImplant Module for Midfoot Fusion Plates
Catalog Number60.900.307
Company DUNS058864308
Company NameCROSSROADS EXTREMITY SYSTEMS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS100810112592467 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

Moist Heat or Steam Sterilization


[00810112592467]

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 Etremity Anatomic Plating System]

008101125925662.0 mm Drill Bit for Standard Technique
00810112592467Implant Module for Midfoot Fusion Plates

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