DENALI® MI Spinal System

FDA UDI

Class II (US FDA UDI)

by K2m, Inc.

Identity

Trade Name: DENALI® MI Spinal System FDA UDI
Generic Name: Bone-screw internal spinal fixation system rod FDA UDI
Device Name: Straight Rod, Bulleted Hex Size Ø5.5x300 mm, Ti FDA UDI
Model / Reference: 1001-A55300 FDA UDI
Description: Straight Rod, Bulleted Hex Size Ø5.5x300 mm, Ti FDA UDI

Identifiers

Catalog Number: 1001-A55300 FDA UDI
Primary DI / UDI-DI: 10888857001640 FDA UDI
FDA Product Code: MNH FDA UDI
KWP FDA UDI
NKB FDA UDI
OSH FDA UDI
MNI FDA UDI
KWQ FDA UDI
GMDN Term: Bone-screw internal spinal fixation system rod FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 FDA UDI
888.3050 FDA UDI
888.3060 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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 5.5 Millimeter FDA UDI
Length — 300 Millimeter FDA UDI

Category: Bone-screw internal spinal fixation system rod

DENALI® MI Spinal System by K2m, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-screw internal spinal fixation system rod.

The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
LnK Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class II
Proficient® Posterior Cervical Spine System — Spine Wave, Inc. · Class II
Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
The JASPER Spinal Fixation System60 — GBS Commonwealth Co., Ltd. · Class II
The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · 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

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Manufacturer

Manufacturer: K2m, Inc.

Sources (1)

FDA UDI dea051a1-d293-45c0-bb29-2491a2526d05 36 fields · synced May 31, 2026