DEVICE: Talon™ DistalFix™ Humeral Nail (B058HTN4083151)

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Device Record History
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Device Identifier (DI) Information
Talon™ DistalFix™ Humeral Nail
HTN408315
In Commercial Distribution
HTN-408-315
Orthopedic Designs North America, Inc.
B058HTN4083151
HIBCC

1
945518848 *Terms of Use
Talon™ DistalFix™ Humeral Nail 4° | Ø8mm | 315mm
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
38153 Humerus intramedullary nail
A rigid rod made of metal or other material intended to be implanted into the intramedullary canal of the humerus to immobilize the ends of a fractured bone in position to promote healing; it may also be used to support the bone in the presence of a pathological condition. It may be a locked or unlocked model and possess components to assist fixation of more proximal or distal conditions. This is a single-use device.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
HSB Rod, Fixation, Intramedullary And Accessories
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K173255 000
No CLOSE

Sterilization
Yes
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 8 Millimeter
Length: 315 Millimeter
Angle: 4 degree
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Device Record Status
2aa0156c-087c-420d-b8c3-16918f05d0c4
February 06, 2025
4
March 16, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
888-635-8535
support@odi-na.com
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