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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
Steinmann Pins, Single diamond, threaded, 1/8-inch (3.2mm) diameter, 9-inch long FDA UDI
Model / Reference
KI-71-709 FDA UDI
Description
Steinmann Pins, Single diamond, threaded, 1/8-inch (3.2mm) diameter, 9-inch long FDA UDI

Identifiers

Catalog Number
KI71709 FDA UDI
Primary DI / UDI-DI
00849771015239 FDA UDI
510(k) Number
K102845 FDA UDI
FDA Product Code
HWC FDA UDI
HRS FDA UDI
HTY FDA UDI
GMDN Term
Orthopaedic bone pin, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
888.3030 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

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 dedcc8c1-0e9a-4de6-a5e6-9f73a69a5ee5 37 fields · synced May 31, 2026