TriLeap Lower Extremity Plating System 04.900.057

GUDID 00810112597035

Lateral Ti Talar Neck Plate, Linear

CROSSROADS EXTREMITY SYSTEMS

Orthopaedic fixation plate, non-bioabsorbable

Primary Device ID	00810112597035
NIH Device Record Key	56558c83-eb70-4c53-a1a6-56d2a7fb6830
Commercial Distribution Status	In Commercial Distribution
Brand Name	TriLeap Lower Extremity Plating System
Version Model Number	Lateral Ti Talar Neck Plate, Linear
Catalog Number	04.900.057
Company DUNS	058864308
Company Name	CROSSROADS EXTREMITY SYSTEMS
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810112597035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K230591

FDA Product Code

HRS	Plate, Fixation, Bone

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

[00810112597035]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-02-29
Device Publish Date	2024-02-21

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00850310006380 - CrossTIE™ H10 Driver Cannulated	2024-09-11 Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe,
00850310006397 - CrossTIE™ 2.0mm Hex Driver Cannulated	2024-09-11 Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe,
00850310006403 - CrossTIE™ Head Drill 3.0mm Cannulated	2024-09-11 Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe,
00850310006434 - CrossTIE™ Reamer 2.2mm	2024-09-11 Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe,
00850310006441 - CrossTIE™ Reamer 2.5mm	2024-09-11 Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe,
00850310006458 - CrossTIE™ Reamer 2.7mm	2024-09-11 Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe,

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