FDA.reportPublic FDA data

Hintermann Series

Primary DI
00841731142351
Brand
Hintermann Series
Company
VILEX LLC
Model
HT-39604
Device description
Hintermann Series Fixation Pin, Non-threaded, Short
Published
2025-09-17
Public version status
Update
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
00841731142351PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841731142351008417311423518417311423510841731142351

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
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
00841731132642REDEMPTION Beaming SystemRPT80-40T-24RPT80-40T-242026-11-03
00841731132659REDEMPTION Beaming SystemRPT80-45T-24RPT80-45T-242026-11-03
00841731132666REDEMPTION Beaming SystemRPT80-50T-24RPT80-50T-242026-11-03
00841731132673REDEMPTION Beaming SystemRPT80-55T-24RPT80-55T-242026-11-03
00841731132680REDEMPTION Beaming SystemRPT80-60T-24RPT80-60T-242026-11-03
00841731132697REDEMPTION Beaming SystemRPT80-65T-24RPT80-65T-242026-11-03
00841731132703REDEMPTION Beaming SystemRPT80-70T-24RPT80-70T-242026-11-03
00841731132710REDEMPTION Beaming SystemRPT80-75T-24RPT80-75T-242026-11-03
00841731132727REDEMPTION Beaming SystemRPT80-80T-24RPT80-80T-242026-11-03
00841731132734REDEMPTION Beaming SystemRPT80-85T-24RPT80-85T-242026-11-03
00841731132741REDEMPTION Beaming SystemRPT80-90T-24RPT80-90T-242026-11-03
00841731132758REDEMPTION Beaming SystemRPT80-95T-24RPT80-95T-242026-11-03
00841731132765REDEMPTION Beaming SystemRPT80-100T-24RPT80-100T-242026-11-03
00841731132772REDEMPTION Beaming SystemRPT80-105T-24RPT80-105T-242026-11-03
00841731132789REDEMPTION Beaming SystemRPT80-110T-24RPT80-110T-242026-11-03
00841731132796REDEMPTION Beaming SystemRPT80-115T-24RPT80-115T-242026-11-03
00841731132802REDEMPTION Beaming SystemRPT80-120T-24RPT80-120T-242026-11-03
00841731132819REDEMPTION Beaming SystemRPT80-125T-24RPT80-125T-242026-11-03
00841731132826REDEMPTION Beaming SystemRPT80-130T-24RPT80-130T-242026-11-03
00841731132833REDEMPTION Beaming SystemRPT80-135T-24RPT80-135T-242026-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841731133588REDEMPTION Beaming SystemVILEX LLCHXI2026-11-03
00841731133595REDEMPTION Beaming SystemVILEX LLCHXI2026-11-03
00842078100127HammerFiXEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078100134HammerFiXEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078100141HammerFiXEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078100295IO FiXEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078100318XMCPEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078101889Jones UnionEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078110126AlignXEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078110263AlignXEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078112267Axis BeamsEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078112281Axis BeamsEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078114735Omni MTPEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078114766Omni MTPEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078116159Omni PlatingEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078116166Omni PlatingEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078116180AlignXEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078119822Axis PlatingEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078123379Omni Stable AFEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078124239Lapidus Joint PrepEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078126066Lapidus Joint PrepEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078137178MetaForeEXTREMITY MEDICAL, LLCHXI2026-10-29
04047844130957DIPLOMATSIGNUS Medizintechnik GmbHHXI2026-10-26
04047844130964DIPLOMATSIGNUS Medizintechnik GmbHHXI2026-10-26
04047844130971DIPLOMATSIGNUS Medizintechnik GmbHHXI2026-08-14
04047844130988DIPLOMATSIGNUS Medizintechnik GmbHHXI2026-08-14
10810128464137WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHXI2026-07-22
00841731135568TITANEX VILEX LLCHXI2026-05-15
00841731137319TITANEX VILEX LLCHXI2026-05-15
00841731137906TITANEXVILEX LLCHXI2026-05-15