Kirschner wire

FDA UDI

Class II (US FDA UDI)

by In2bones

Identity

Trade Name: Kirschner wire FDA UDI
Generic Name: Orthopaedic bone pin, non-bioabsorbable FDA UDI
Device Name: KIRSCHNER WIRES NS Dia 2.2MM LENGTH 100MM 2 SHARP TIPS FDA UDI
Model / Reference: K20 NS220 FDA UDI
Description: KIRSCHNER WIRES NS Dia 2.2MM LENGTH 100MM 2 SHARP TIPS FDA UDI

Identifiers

Catalog Number: K20 NS220 FDA UDI
Primary DI / UDI-DI: 03760225715529 FDA UDI
510(k) Number: K153204 FDA UDI
FDA Product Code: HTY FDA UDI
FZX FDA UDI
GMDN Term: Orthopaedic bone pin, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
878.4800 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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 100 Millimeter FDA UDI
Outer Diameter — 2.2 Millimeter FDA UDI

Category: Orthopaedic bone pin, non-bioabsorbable

Kirschner wire by In2bones — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone pin, non-bioabsorbable.

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IlluminOss — ILLUMINOSS MEDICAL INC. · Class II
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

Cleared under the same submission

K153204 also covers:

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: In2bones

Sources (1)

FDA UDI 0d36d7a8-e543-4f3a-a8f7-21915a853cea 37 fields · synced May 30, 2026