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Key Surgical K-Wires and Steinmann Pins

FDA UDI

Class II (US FDA UDI)

by Key Surgical, LLC

Identity

Trade Name
Key Surgical K-Wires and Steinmann Pins FDA UDI
Generic Name
Orthopaedic bone pin, non-bioabsorbable FDA UDI
Device Name
K-Wires, Double trocar, threaded, .062-inch (1.6mm) diameter, 9-inch long FDA UDI
Model / Reference
KI-71-303 FDA UDI
Description
K-Wires, Double trocar, threaded, .062-inch (1.6mm) diameter, 9-inch long FDA UDI

Identifiers

Catalog Number
KI71303 FDA UDI
Primary DI / UDI-DI
00849771012924 FDA UDI
510(k) Number
K102845 FDA UDI
FDA Product Code
HRS FDA UDI
HWC FDA UDI
HTY FDA UDI
GMDN Term
Orthopaedic bone pin, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
888.3040 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Guidewire Diameter — 0.062 Inch FDA UDI
Guidewire Length — 9 Inch FDA UDI

Key Surgical K-Wires and Steinmann Pins by Key Surgical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K102845 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Key Surgical, LLC

Sources (1)

  • FDA UDI 0478d603-af10-4613-a417-bba707b303d9 38 fields · synced Jun 1, 2026