NILE™ Proximal Fixation System

FDA UDI

Class II (US FDA UDI)

by K2m, Inc.

Identity

Trade Name: NILE™ Proximal Fixation System FDA UDI
Generic Name: Cannulated surgical drill bit, single-use FDA UDI
Device Name: Semi-Adj Transverse Connector Dual Slot, Size 37 mm FDA UDI
Model / Reference: 5401-70037A FDA UDI
Description: Semi-Adj Transverse Connector Dual Slot, Size 37 mm FDA UDI

Identifiers

Catalog Number: 5401-70037A FDA UDI
Primary DI / UDI-DI: 10888857291232 FDA UDI
FDA Product Code: OWI FDA UDI
GMDN Term: Cannulated surgical drill bit, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3010 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

Dimensions & Sizes

Size: Length — 37 Millimeter FDA UDI
Outer Diameter — 6 Millimeter FDA UDI
Outer Diameter — 5.5 Millimeter FDA UDI

Category: Cannulated surgical drill bit, single-use

NILE™ Proximal Fixation System by K2m, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: K2m, Inc.

Sources (1)

FDA UDI a1f3c130-eebe-4242-aedd-7de9add6b55f 36 fields · synced May 31, 2026