DEVICE: ODI Talon™ Intramedullary Hip Nail (B058THN135380L1)

Device Identifier (DI) Information

ODI Talon™ Intramedullary Hip Nail
THN135380L
In Commercial Distribution

Orthopedic Designs North America, Inc.
B058THN135380L1
HIBCC

1
945518848 *Terms of Use
Proximal Femoral Nail, 135 Degrees - 380mm Long: Left (11mm Distal Diameter)
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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
Femur nail, non-sterile A non-sterile rod made of metal or other material which, when inserted into the intramedullary canal of the femur, acts to immobilize by holding the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. The device 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 intended to be sterilized prior to use.
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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 [?]
K033286 000
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Sterilization

No
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
Device Size Text, specify: Left
Angle: 135 degree
Length: 380 Millimeter
Outer Diameter: 11 Millimeter
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Device Record Status

adf43c4a-2118-49b0-a699-4222dd4046b9
July 06, 2018
3
October 22, 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)

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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

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