FDA.reportPublic FDA data

Hintermann Series

Primary DI
00841731134769
Brand
Hintermann Series
Company
VILEX LLC
Model
HT-39900
Device description
Hintermann Series K-wire 1 sharp 1 blunt 2.4mm L 230mm
Published
2026-01-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXIPASSER, WIRE, ORTHOPEDIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXIPasser, Wire, OrthopedicOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240475000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240475000Hintermann Series H2 Total Ankle SystemVilex, LLC2024-12-02HSN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841731134769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841731134769008417311347698417311347690841731134769

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic intraoperative positioning pin, reusableA nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as a wire or temporary K-wire. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)521-5002info@vilex.com

Regulatory Flags#

DUNS number
117502293
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841731140395ARTEMIS FUZEAV40-20T-16V2026-07-22
00841731140401ARTEMIS FUZEAV40-22T-16V2026-07-22
00841731140418ARTEMIS FUZEAV40-24T-16V2026-07-22
00841731140425ARTEMIS FUZEAV40-26T-16V2026-07-22
00841731140432ARTEMIS FUZEAV40-28T-16V2026-07-22
00841731140449ARTEMIS FUZEAV40-30T-16V2026-07-22
00841731140456ARTEMIS FUZEAV40-32T-16V2026-07-22
00841731140463ARTEMIS FUZEAV40-34T-16V2026-07-22
00841731140470ARTEMIS FUZEAV40-36T-16V2026-07-22
00841731140487ARTEMIS FUZEAV40-38T-16V2026-07-22
00841731140494ARTEMIS FUZEAV40-40T-16V2026-07-22
00841731140500ARTEMIS FUZEAV40-42T-16V2026-07-22
00841731140517ARTEMIS FUZEAV40-44T-16V2026-07-22
00841731140524ARTEMIS FUZEAV40-46T-16V2026-07-22
00841731140531ARTEMIS FUZEAV40-48T-16V2026-07-22
00841731140548ARTEMIS FUZEAV40-50T-16V2026-07-22
00841731140555ARTEMIS FUZEAV40-52T-16V2026-07-22
00841731140562ARTEMIS FUZEAV40-54T-16V2026-07-22
00841731140593ARTEMIS FUZEAV30-16T-11V2026-07-22
00841731140609ARTEMIS FUZEAV30-18T-11V2026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810128464137WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHXI2026-07-22
00841731135568TITANEX VILEX LLCHXI2026-05-15
00841731137319TITANEX VILEX LLCHXI2026-05-15
00841731137906TITANEXVILEX LLCHXI2026-05-15
00841731138095TITANEX VILEX LLCHXI2026-05-15
00841731142870TITANEX VILEX LLCHXI2026-05-15
00841731142887TITANEX VILEX LLCHXI2026-05-15
00841731146717TITANEXVILEX LLCHXI2026-05-15
00841731146724TITANEXVILEX LLCHXI2026-05-15
00841731146731TITANEXVILEX LLCHXI2026-05-15
00841731147141TITANEX VILEX LLCHXI2026-05-15
00889795152671Monkey Rings™ External Fixation SystemParagon 28, Inc.HXI2026-05-06
00889795152688Monkey Rings™ External Fixation SystemParagon 28, Inc.HXI2026-05-06
00889795152695Monkey Rings™ External Fixation SystemParagon 28, Inc.HXI2026-05-06
B8034803860ORTHOMEDORTHO-MED, INC.HXI2026-04-16
B8034803880ORTHOMEDORTHO-MED, INC.HXI2026-04-16
00840311246830Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.HXI2026-03-18
10810128462645Nitinol Loop Passer MEDACTAT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHXI2026-02-09
06974940306369endophixSuzhou Endophix Co., Ltd.HXI2025-12-12
06974940306147endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306154endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306161endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306178endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306185endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306192endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306208endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306215endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306222endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306239endophixSuzhou Endophix Co., Ltd.HXI2025-12-05
06974940306246endophixSuzhou Endophix Co., Ltd.HXI2025-12-05