K-Wire, Ø1.1 x 120mm

FDA UDI

Class II (US FDA UDI)

by Miami Device Solutions

Identity

Trade Name: K-Wire, Ø1.1 x 120mm FDA UDI
Generic Name: Orthopaedic bone wire FDA UDI
Device Name: K-Wire, Ø1.1 x 120mm FDA UDI
Model / Reference: MDS001011120R FDA UDI
Description: K-Wire, Ø1.1 x 120mm FDA UDI

Identifiers

Catalog Number: MDS00101120R FDA UDI
Primary DI / UDI-DI: 10812269020586 FDA UDI
FDA Product Code: HWC FDA UDI
HRS FDA UDI
GMDN Term: Orthopaedic bone wire FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
888.3030 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

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: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Orthopaedic bone wire

K-Wire, Ø1.1 x 120mm by Miami Device Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone wire.

mahe medical GmbH — mahe medical gmbh · Class II
SALVATION™ — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
De Soutter Medical — De Soutter Medical, Ltd. · Class I
SMOOTH K-WIRE, DOUBLE END TROCAR POINT — Biomet Orthopedics, Inc. · Class II
mahe medical GmbH — mahe medical gmbh · Class II
OIC Variable Angle Small Fragment Locking Plate System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
THP™ Hip Fracture Plating System — Biomet Orthopedics, Inc. · Class II
gSource — GSOURCE, LLC. · 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 II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Miami Device Solutions

Sources (1)

FDA UDI efecb32b-6c22-44af-8a75-e48fc047de30 35 fields · synced Jun 8, 2026