DEVICE: Talon™ DistalFix™ End Cap (B058SLN1550101)

Device Identifier (DI) Information

Talon™ DistalFix™ End Cap
SLN155010
In Commercial Distribution

Orthopedic Designs North America, Inc.
B058SLN1550101
HIBCC

1
945518848 *Terms of Use
Talon™ DistalFix™ End Cap 15.5mm x 10mm
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Bone nail end-cap A small, sterile, rounded plug or cover designed to seal the proximal end of an orthopaedic nail after implantation. It prevents the healing tissue from growing inside the hollow nail that has been implanted to treat a damaged bone (e.g., a fracture) and facilitates nail extraction. It is typically made of metal [e.g., high-grade stainless steel, titanium (Ti)], and is available in a variety of sizes typically to fit the inner dimensions of the nail. It may also be used to securely lock the most proximal oblique locking screw or help extend the length of a nail when necessary. It may be used with trochanteric, femoral, humeral, supracondylar or tibial nails. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
HSB Rod, Fixation, Intramedullary And Accessories
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K111352 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Length: 10 Millimeter
Outer Diameter: 15.5 Millimeter
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Device Record Status

3922caf0-b0d6-42a0-a4d0-996008c023b7
July 06, 2018
3
October 19, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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