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DENALI Spinal System

FDA UDI

Class I (US FDA UDI)

by K2m, Inc.

Identity

Trade Name
DENALI Spinal System FDA UDI
Generic Name
Bone tap, reusable FDA UDI
Device Name
Cortical Tap Quick Connect Size Ø4.5 mm FDA UDI
Model / Reference
101-90224 FDA UDI
Description
Cortical Tap Quick Connect Size Ø4.5 mm FDA UDI

Identifiers

Catalog Number
101-90224 FDA UDI
Primary DI / UDI-DI
10888857010659 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Bone tap, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

Yes

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

Category: Bone tap, reusable

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

Similar devices

Also classified as Bone tap, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
K2m, Inc.

Sources (1)

  • FDA UDI 7849cc8b-a1f3-43c4-b4fe-af2629a1ccb7 35 fields · synced May 30, 2026