Torque Limiting Handle

FDA UDI

Class I (US FDA UDI)

by Curvafix Inc

Identity

Trade Name: Torque Limiting Handle FDA UDI
Generic Name: Surgical instrument handle, torque-limiting FDA UDI
Device Name: A surgical instrument that allows a surgeon to insert the CurvaFix IM Implant into the pelvis without exerting excess torque or force on the implant. FDA UDI
Model / Reference: CTH-001 FDA UDI
Description: A surgical instrument that allows a surgeon to insert the CurvaFix IM Implant into the pelvis without exerting excess torque or force on the implant. FDA UDI

Identifiers

Catalog Number: CTH-001 FDA UDI
Primary DI / UDI-DI: 10855068008379 FDA UDI
FDA Product Code: LXH FDA UDI
HWC FDA UDI
HSB FDA UDI
GMDN Term: Surgical instrument handle, torque-limiting FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
888.3040 FDA UDI
888.3020 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

Yes

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

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: Surgical instrument handle, torque-limiting

Torque Limiting Handle by Curvafix Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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KONG-TL VBR System, Torque Limiter with Coupling, 1/4'' Coupling, 1 Nm — Icotec · Class II

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 I	Pending data

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Manufacturer

Manufacturer: Curvafix Inc

Sources (1)

FDA UDI ab1747e5-eddf-4ace-b203-1bd7bd6d8fe5 35 fields · synced Jun 1, 2026