FDA.reportPublic FDA data

Talon™ DistalFix™ HTN End Cap

Primary DI
B058HTN10C151
Brand
Talon™ DistalFix™ HTN End Cap
Company
Orthopedic Designs North America, Inc.
Model
HTN10C15
Catalog number
HTN-10-C15
Device description
Talon™ DistalFix™ HTN End Cap 10mm x 15mm
Published
2018-03-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173255000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173255000Talon DistalFix Humeral NailOrthopedic Designs North America, Inc.2018-02-22HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B058HTN10C151PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone nail end-cap, sterileA small, sterile, rounded plug, cover or threaded screw designed to seal the proximal end of an orthopaedic nail implanted to treat a damaged bone (e.g., a fracture), to prevent healing tissue from growing into the hollow nail and to facilitate nail extraction. It is typically made of metal [e.g., high-grade stainless steel, titanium (Ti)], and is available in a variety of sizes. It may also be used to securely lock the most proximal oblique locking screw or help extend the length of a nail when necessary. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length15Millimeter
Outer Diameter10Millimeter

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
Lot or batch
true
Manufacturing date on label
true
Expiration 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
B058HTN10C15L1Talon™ DistalFix™ HTN End Cap LockingHTN10C15LHTN-10-C15-L2019-03-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982660086AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660109AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660123AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660147AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660161AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660185AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660208AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660222AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660246AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660260AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660284AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660307AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660321AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
B058AHN08165L1Atlas™ Humeral Nail SystemOrthopedic Designs North America, Inc.HSB2026-05-29
B058AHN08165R1Atlas™ Humeral Nail SystemOrthopedic Designs North America, Inc.HSB2026-05-29
10855068008423Lock ActivatorCURVAFIX, INC.HSB2022-06-20
10855068008492Inserter/ExtractorCURVAFIX, INC.HSB2022-06-20
10855068008539Sterilization Case, OuterCURVAFIX, INC.HSB2022-06-20
10855068008621Ring Lock, Long InserterCURVAFIX, INC.HSB2022-06-20
03701037310649FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310656FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310663FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310670FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310687FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310694FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310700FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310717FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310724FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310731FLEX NAILFX SOLUTIONSHSB2021-10-26
03701037310748FLEX NAILFX SOLUTIONSHSB2021-10-26