FDA.reportPublic FDA data

Hintermann Series

Primary DI
00841731134714
Brand
Hintermann Series
Company
VILEX LLC
Model
HT-39711
Device description
Hintermann Series Talar Peg Drill 4.5mm
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
HTWBIT, DRILL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

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
00841731134714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841731134714008417311347148417311347140841731134714

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
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
09353903030461OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-11-04
09353903030478OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-11-04
00841731133519REDEMPTION Beaming SystemVILEX LLCHTW2026-11-03
00841731133526REDEMPTION Beaming SystemVILEX LLCHTW2026-11-03
00841731133533REDEMPTION Beaming SystemVILEX LLCHTW2026-11-03
00841731133540REDEMPTION Beaming SystemVILEX LLCHTW2026-11-03
00841731133557REDEMPTION Beaming SystemVILEX LLCHTW2026-11-03
00841731133694REDEMPTION Beaming SystemVILEX LLCHTW2026-11-03
00889024713727G7® TM Acetabular SystemZimmer, Inc.HTW2026-11-03
00713864000313EF1Medshape, Inc.HTW2026-11-02
00713864000320EF1Medshape, Inc.HTW2026-11-02
07630894822513APTUSMedartis AGHTW2026-11-02
07630894822520APTUSMedartis AGHTW2026-11-02
07630894822605APTUSMedartis AGHTW2026-11-02
07630894822612APTUSMedartis AGHTW2026-11-02
07630894822667APTUSMedartis AGHTW2026-11-02
07630894822674APTUSMedartis AGHTW2026-11-02
03700569679279Newclip InstrumentsNEWCLIP TECHNICSHTW2026-10-30
03700569679286Newclip InstrumentsNEWCLIP TECHNICSHTW2026-10-30
03700569679293Newclip InstrumentsNEWCLIP TECHNICSHTW2026-10-30
03700569679309Newclip InstrumentsNEWCLIP TECHNICSHTW2026-10-30
00842078100363IO FiXEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078100370IO FiXEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078100387IO FiXEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078101773XMCPEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078103197IO FiX 2.0EXTREMITY MEDICAL, LLCHTW2026-10-29
00842078103227IO FiX 2.0EXTREMITY MEDICAL, LLCHTW2026-10-29
00842078109465CarpalFiXEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078110379AlignXEXTREMITY MEDICAL, LLCHTW2026-10-29
00842078112304Axis BeamsEXTREMITY MEDICAL, LLCHTW2026-10-29