Hintermann Series H2

Basic Information

• Brand Name: Hintermann Series H2
• Primary DI: 00841731128010
• Version / Model: HT-38617
• Company Name: VILEX LLC
• Labeler DUNS: 117502293
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-05
• Public Version: 1
• Public Version Date: 2025-09-15
• Public Version Status: New
• Public Device Record Key: 8768728c-bac8-4fdb-b255-ac72dd4bdf88

Device Description

H2 Vit E Poly Assembly, Sz 6, Left, 7mm, Anterior

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HSN	PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER	Orthopedic	888.3110	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48180	Ankle prosthesis bearing	A sterile implantable device made of polyethylene (PE) designed to articulate the tibial and talar components of a total ankle prosthesis.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841731128010	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K240475	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			6 A LEFT 7mm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a dry place.