ODI Talon™ Intramedullary Hip Nail

GUDID B058THN1302101

Proximal Femoral Nail, 130 degree - 210mm (11mm Distal Diameter)

Orthopedic Designs North America, Inc.

Femur nail, non-sterile
Primary Device IDB058THN1302101
NIH Device Record Keyf4132753-26e6-4013-a997-b7fe56933e85
Commercial Distribution StatusIn Commercial Distribution
Brand NameODI Talon™ Intramedullary Hip Nail
Version Model NumberTHN130210
Company DUNS945518848
Company NameOrthopedic Designs North America, Inc.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com
Phone888-635-8535
Emailsupport@odi-na.com

Device Dimensions

Angle130 degree
Length210 Millimeter
Outer Diameter11 Millimeter
Angle130 degree
Length210 Millimeter
Outer Diameter11 Millimeter
Angle130 degree
Length210 Millimeter
Outer Diameter11 Millimeter
Angle130 degree
Length210 Millimeter
Outer Diameter11 Millimeter
Angle130 degree
Length210 Millimeter
Outer Diameter11 Millimeter
Angle130 degree
Length210 Millimeter
Outer Diameter11 Millimeter
Angle130 degree
Length210 Millimeter
Outer Diameter11 Millimeter
Angle130 degree
Length210 Millimeter
Outer Diameter11 Millimeter
Angle130 degree
Length210 Millimeter
Outer Diameter11 Millimeter
Angle130 degree
Length210 Millimeter
Outer Diameter11 Millimeter
Angle130 degree
Length210 Millimeter
Outer Diameter11 Millimeter
Angle130 degree
Length210 Millimeter
Outer Diameter11 Millimeter
Angle130 degree
Length210 Millimeter
Outer Diameter11 Millimeter
Angle130 degree
Length210 Millimeter
Outer Diameter11 Millimeter
Angle130 degree
Length210 Millimeter
Outer Diameter11 Millimeter
Angle130 degree
Length210 Millimeter
Outer Diameter11 Millimeter
Angle130 degree
Length210 Millimeter
Outer Diameter11 Millimeter
Angle130 degree
Length210 Millimeter
Outer Diameter11 Millimeter
Angle130 degree
Length210 Millimeter
Outer Diameter11 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB058THN1302101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDSNail, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B058THN1302101]

Moist Heat or Steam Sterilization

[B058THN1302101]

Moist Heat or Steam Sterilization

[B058THN1302101]

Moist Heat or Steam Sterilization

[B058THN1302101]

Moist Heat or Steam Sterilization

[B058THN1302101]

Moist Heat or Steam Sterilization

[B058THN1302101]

Moist Heat or Steam Sterilization

[B058THN1302101]

Moist Heat or Steam Sterilization

[B058THN1302101]

Moist Heat or Steam Sterilization

[B058THN1302101]

Moist Heat or Steam Sterilization

[B058THN1302101]

Moist Heat or Steam Sterilization

[B058THN1302101]

Moist Heat or Steam Sterilization

[B058THN1302101]

Moist Heat or Steam Sterilization

[B058THN1302101]

Moist Heat or Steam Sterilization

[B058THN1302101]

Moist Heat or Steam Sterilization

[B058THN1302101]

Moist Heat or Steam Sterilization

[B058THN1302101]

Moist Heat or Steam Sterilization

[B058THN1302101]

Moist Heat or Steam Sterilization

[B058THN1302101]

Moist Heat or Steam Sterilization

[B058THN1302101]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-22

On-Brand Devices [ODI Talon™ Intramedullary Hip Nail]

B058THN135380R1Proximal Femoral Nail, 135 Degrees - 380mm Long: Right (11mm Distal Diameter)
B058THN135380L1Proximal Femoral Nail, 135 Degrees - 380mm Long: Left (11mm Distal Diameter)
B058THN135340R1Proximal Femoral Nail, 135 Degrees - 340mm Long: Right (11mm Distal Diameter)
B058THN135340L1Proximal Femoral Nail, 135 Degrees - 340mm Long: Left (11mm Distal Diameter)
B058THN1352101Proximal Femoral Nail, 135 degree - 210mm (11mm Distal Diameter)
B058THN130380R1Proximal Femoral Nail, 130 Degrees - 380mm Long: Right (11mm Distal Diameter)
B058THN130380L1Proximal Femoral Nail, 130 Degrees - 380mm Long: Left (11mm Distal Diameter)
B058THN130340R1Proximal Femoral Nail, 130 Degrees - 340mm Long: Right (11mm Distal Diameter)
B058THN130340L1Proximal Femoral Nail, 130 Degrees - 340mm Long: Left (11mm Distal Diameter)
B058THN1302101Proximal Femoral Nail, 130 degree - 210mm (11mm Distal Diameter)
B058THN125380R1Proximal Femoral Nail, 125 Degrees - 380mm Long: Right (11mm Distal Diameter)
B058THN125380L1Proximal Femoral Nail, 125 Degrees - 380mm Long: Left (11mm Distal Diameter)
B058THN125340R1Proximal Femoral Nail, 125 Degrees - 340mm Long: Right (11mm Distal Diameter)
B058THN125340L1Proximal Femoral Nail, 125 Degrees - 340mm Long: Left (11mm Distal Diameter)
B058THN1252101Proximal Femoral Nail, 125 degree - 210mm (11mm Distal Diameter)
B058THN0011Lag Sleeve
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.