FDA.reportPublic FDA data

Talon Driver

Primary DI
B058ODIU091
Brand
Talon Driver
Company
Orthopedic Designs North America, Inc.
Model
ODIU09
Catalog number
ODI-U09
Device description
Talon Driver
Published
2023-06-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B058ODIU091PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
888-635-8535support@odi-na.com

Regulatory Flags#

DUNS number
945518848
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B058AHN08165L1Atlas™ Humeral Nail SystemAHN08165LAHN-08-165L2026-05-29
B058AHN08165R1Atlas™ Humeral Nail SystemAHN08165RAHN-08-165R2026-05-29
B058AHN5026NS1Atlas™ Humeral Nail SystemAHN5026NSAHN-5-026NS2026-05-04
B058AHN5028NS1Atlas™ Humeral Nail SystemAHN5028NSAHN-5-028NS2026-05-04
B058AHN5030NS1Atlas™ Humeral Nail SystemAHN5030NSAHN-5-030NS2026-05-04
B058AHN5032NS1Atlas™ Humeral Nail SystemAHN5032NSAHN-5-032NS2026-05-04
B058AHN11C00L1Atlas™ Humeral Nail SystemAHN11C00LAHN-11-C00-L2025-01-28
B058AHN11C05L1Atlas™ Humeral Nail SystemAHN11C05LAHN-11-C05-L2025-01-28
B058AHN11C10L1Atlas™ Humeral Nail SystemAHN11C10LAHN-11-C10-L2025-01-28
B058ART13C001ART End CapART13C00ART-13-C002021-11-29
B058ART13C051ART End CapART13C05ART-13-C052021-11-29
B058ART13C101ART End CapART13C10ART-13-C102021-11-29
B058ART13C151ART End CapART13C15ART-13-C152021-11-29
B058HTN10C011Talon™ DistalFix™ HTN End CapHTN10C01HTN-10-C012018-03-16
B058HTN10C01L1Talon™ DistalFix™ HTN End Cap LockingHTN10C01LHTN-10-C01-L2019-03-07
B058HTN10C051Talon™ DistalFix™ HTN End CapHTN10C05HTN-10-C052018-03-16
B058HTN10C05L1Talon™ DistalFix™ HTN End Cap LockingHTN10C05LHTN-10-C05-L2019-03-07
B058HTN10C101Talon™ DistalFix™ HTN End CapHTN10C10HTN-10-C102018-03-16
B058HTN10C10L1Talon™ DistalFix™ HTN End Cap LockingHTN10C10LHTN-10-C10-L2019-03-07
B058HTN10C151Talon™ DistalFix™ HTN End CapHTN10C15HTN-10-C152018-03-16

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