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: Contoured Rod, Bulleted Hex Size Ø5.5x35 mm, Ti FDA UDI
Model / Reference: 1001-E5535 FDA UDI
Description: Contoured Rod, Bulleted Hex Size Ø5.5x35 mm, Ti FDA UDI

Identifiers

Catalog Number: 1001-E5535 FDA UDI
Primary DI / UDI-DI: 10888857001954 FDA UDI
FDA Product Code: NKB FDA UDI
MNI FDA UDI
OSH FDA UDI
MNH FDA UDI
KWP 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 — 35 Millimeter FDA UDI

Category: Bone-screw internal spinal fixation system rod

The DENALI MI Spinal System is a cutting-edge, implantable rod designed for longitudinal spinal fixation in the treatment of various spinal instabilities or deformities. It features a contoured design, available in flexible and rigid forms, allowing for precise control over spine mobility. This rod is made from titanium and has undergone extensive testing to ensure its safety and efficacy.

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 6e279bd3-742f-43fc-99a5-54f081d9d5aa 36 fields · synced Jul 20, 2026