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DENALI® Spinal System

FDA UDI

Class II (US FDA UDI)

by K2m, Inc.

Identity

Trade Name
DENALI® Spinal System FDA UDI
Generic Name
Bone-screw internal spinal fixation system connector FDA UDI
Device Name
Rod Connector, Closed, Narrow Size Ø5.5/Ø6.35 FDA UDI
Model / Reference
5501-86363EN FDA UDI
Description
Rod Connector, Closed, Narrow Size Ø5.5/Ø6.35 FDA UDI

Identifiers

Catalog Number
5501-86363EN FDA UDI
Primary DI / UDI-DI
10888857112568 FDA UDI
FDA Product Code
KWQ FDA UDI
MNH FDA UDI
OSH FDA UDI
MNI FDA UDI
NKB FDA UDI
KWP FDA UDI
GMDN Term
Bone-screw internal spinal fixation system connector FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3060 FDA UDI
888.3070 FDA UDI
888.3050 FDA UDI
Commercial Distribution
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
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 5.5 Millimeter FDA UDI
Outer Diameter — 6.35 Millimeter FDA UDI

Category: Bone-screw internal spinal fixation system connector

DENALI® 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 connector.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
K2m, Inc.

Sources (1)

  • FDA UDI ccf8325b-34c0-4965-a734-34ec494927fb 36 fields · synced Jun 7, 2026