Tension Bolt

FDA UDI

Class II (US FDA UDI)

by I.T.S. GmbH

Identity

Trade Name: Tension Bolt FDA UDI
Generic Name: Orthopaedic implant aiming arm FDA UDI
Device Name: Tension Bolt, Short FDA UDI
Model / Reference: 680859 FDA UDI
Description: Tension Bolt, Short FDA UDI

Identifiers

Catalog Number: 680859 FDA UDI
Primary DI / UDI-DI: 09120034305603 FDA UDI
FDA Product Code: HTN FDA UDI
GMDN Term: Orthopaedic implant aiming arm FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic implant aiming arm

Tension Bolt by I.T.S. GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: I.T.S. GmbH

Sources (1)

FDA UDI be272748-349c-4592-97e7-a665582594bb 34 fields · synced Jun 8, 2026