Guide Pin, 2.8mm Threaded

FDA UDI

Class II (US FDA UDI)

by Curvafix Inc

Identity

Trade Name: Guide Pin, 2.8mm Threaded FDA UDI
Generic Name: Orthopaedic guidewire, reusable FDA UDI
Device Name: A threaded guidewire used to make the initial entry into the pelvic bone in the intended location and angle for the CurvaFix Implant. FDA UDI
Model / Reference: GPT-001 FDA UDI
Description: A threaded guidewire used to make the initial entry into the pelvic bone in the intended location and angle for the CurvaFix Implant. FDA UDI

Identifiers

Catalog Number: GPT-001 FDA UDI
Primary DI / UDI-DI: 10855068008515 FDA UDI
FDA Product Code: LHX FDA UDI
GMDN Term: Orthopaedic guidewire, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.5800 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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic guidewire, reusable

Guide Pin, 2.8mm Threaded by Curvafix Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthopaedic guidewire, reusable.

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VERTECEM — Synthes GmbH · Class IIa
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ZERO-P — Synthes GmbH · Class IIa
Guidewire, Nitinol, Double Blunt, 1.19 x 610mm — Captiva Spine · Class I

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: Curvafix Inc

Sources (1)

FDA UDI f26ef0a0-3c99-4179-ace3-e2f48fc9b0ae 35 fields · synced Jun 1, 2026