Armada

FDA UDI

Class II (US FDA UDI)

by Nuvasive, Inc.

Identity

Trade Name: Armada FDA UDI
Generic Name: Bone tap, reusable FDA UDI
Device Name: Armada Ti Tap, 8.5mm Double Lead FDA UDI
Model / Reference: 7459185 FDA UDI
Description: Armada Ti Tap, 8.5mm Double Lead FDA UDI

Identifiers

Primary DI / UDI-DI: 00887517485397 FDA UDI
510(k) Number: K112709 FDA UDI
FDA Product Code: ETN FDA UDI
GMDN Term: Bone tap, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.1820 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Category: Bone tap, reusable

Armada by Nuvasive, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Nautilus Spinal System — Life Spine, Inc. · Class II

Cleared under the same submission

K112709 also covers:

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: Nuvasive, Inc.

Sources (1)

FDA UDI dc58b790-ac5b-4dde-945c-f07e70df5e6a 35 fields · synced Jun 8, 2026