Guide Pin - 3.2 mm Dia LH Threaded Tip

FDA UDIEUDAMED

Class I (US FDA UDI)

by Si-Bone Inc.

Identity

Trade Name: Guide Pin - 3.2 mm Dia LH Threaded Tip FDA UDI
Generic Name: Orthopaedic bone pin, non-bioabsorbable FDA UDI
Device Name: Guide Pin - 3.2 mm Dia LH Threaded Tip FDA UDI
Model / Reference: 501385 FDA UDI
Description: Guide Pin - 3.2 mm Dia LH Threaded Tip FDA UDI

Identifiers

Primary DI / UDI-DI: 00810055521951 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Orthopaedic bone pin, non-bioabsorbable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

FDA UDI

Lot / Batch Number

Yes

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 bone pin, non-bioabsorbable

Guide Pin - 3.2 mm Dia LH Threaded Tip by Si-Bone Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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Also classified as Orthopaedic bone pin, non-bioabsorbable.

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XtraFix® External Fixation System — Zimmer, Inc. · Class II
CALIBRATED GUIDE WIRE, THREADED TROCAR POINT — Biomet Orthopedics, Inc. · Class II
TRAUMA FIXATION SYSTEMS — Biomet Orthopedics, Inc. · Class II
SMART TSF — Smith & Nephew, Inc. · Class II

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Si-Bone Inc.

Sources (2)

FDA UDI 5da7cb83-b962-46b7-a7c1-5521d5ffc902 34 fields · synced Jun 20, 2026
EUDAMED 1 fields · synced Jun 1, 2026