FDA.report

Hintermann Series

Primary DI
00841731125743
Company
VILEX LLC
Model
HT-39104
Device description
Hintermann Series Tibial Trial, Right, Size 4
Published
2025-09-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Regulatory Flags

DUNS number
117502293
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00841731125743PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00841731125743PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2Orthopedic888.3110YEligible

Premarket Submissions

SubmissionSupplement
K240475000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K240475000Hintermann Series H2 Total Ankle SystemVilex, LLC2024-12-02HSN

GMDN Terms

TermDefinition
Ankle prosthesis trial, reusableA copy of a final prosthesis designed to be used during ankle replacement surgery to determine the correct alignment, size, and fit of the final tibial, talar or bearing prosthesis component. It is one of a set, or a set, of graduated sizes and is typically made of synthetic polymer or metal material. This is a reusable device.

Device Sizes

TypeValueText
Device Size Text, specify0N/A

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place
Special Storage Condition, Specify00Store in a dry place.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)521-5002info@vilex.com

Other Devices From This Company

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00841731149077DYNEX MICROMR-900-PE-04MR-900-PE-042026-03-03
00841731137548TITANEX TH20-16T-092026-02-09
00841731137555TITANEX TH20-18T-092026-02-09
00841731137562TITANEX TH20-20T-092026-02-09
00841731137579TITANEX TH20-22T-092026-02-09
00841731137586TITANEX TH20-24T-092026-02-09
00841731137593TITANEX TH20-26T-092026-02-09
00841731137609TITANEX TH20-28T-092026-02-09
00841731137616TITANEX TH20-30T-092026-02-09
00841731137623TITANEX TH20-32T-092026-02-09
00841731137630TITANEX TH20-34T-092026-02-09
00841731137647TITANEX TH20-36T-092026-02-09
00841731137654TITANEX TH20-38T-092026-02-09
00841731137661TITANEX TH20-40T-092026-02-09
00841731137678TITANEX TH20-42T-092026-02-09
00841731137685TITANEX TH20-44T-092026-02-09
00841731137692TITANEX TH20-46T-092026-02-09
00841731137708TITANEX TH20-48T-092026-02-09

Other Devices Sharing Product Codes

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10885862655714VantageExactech, Inc.HSN2026-03-19
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10885862656841VantageExactech, Inc.HSN2026-03-10
10885862656858VantageExactech, Inc.HSN2026-03-10
10885862656865VantageExactech, Inc.HSN2026-03-10
10885862656872VantageExactech, Inc.HSN2026-03-10
10885862656889VantageExactech, Inc.HSN2026-03-10
10885862656896VantageExactech, Inc.HSN2026-03-10
10885862656902VantageExactech, Inc.HSN2026-03-10
10885862656919VantageExactech, Inc.HSN2026-03-10
10885862656926VantageExactech, Inc.HSN2026-03-10
10885862656933VantageExactech, Inc.HSN2026-03-10
10885862656940VantageExactech, Inc.HSN2026-03-10
00889795154026APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-02-19
00840097533681Kinos Total Ankle InstrumentationRestor3d, Inc.HSN2025-12-12
00840097533698Kinos Total Ankle InstrumentationRestor3d, Inc.HSN2025-12-12
00840097533704Kinos Total Ankle InstrumentationRestor3d, Inc.HSN2025-12-12
00840097535951Kinos Total Ankle InstrumentationRestor3d, Inc.HSN2025-12-12
00841731125385Hintermann Series VILEX LLCHSN2025-09-17
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00841731125750Hintermann Series VILEX LLCHSN2025-09-17
00841731125767Hintermann Series VILEX LLCHSN2025-09-17
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00841731126016Hintermann Series VILEX LLCHSN2025-09-17
00841731126023Hintermann Series VILEX LLCHSN2025-09-17
00841731126030Hintermann Series VILEX LLCHSN2025-09-17
00841731134592Hintermann Series VILEX LLCHSN2025-09-17