Armada

FDA UDI

Class II (US FDA UDI)

by Nuvasive, Inc.

Identity

Trade Name: Armada FDA UDI
Generic Name: Spinal bone screw, non-bioabsorbable FDA UDI
Device Name: ARM15T Screw, 5.5x40mm PLS FDA UDI
Model / Reference: 8255540 FDA UDI
Description: ARM15T Screw, 5.5x40mm PLS FDA UDI

Identifiers

Primary DI / UDI-DI: 00887517224019 FDA UDI
510(k) Number: K092287 FDA UDI
K121619 FDA UDI
FDA Product Code: KWP FDA UDI
MNI FDA UDI
NKB FDA UDI
MNH FDA UDI
KWQ FDA UDI
GMDN Term: Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3050 FDA UDI
888.3070 FDA UDI
888.3060 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Category: Spinal bone screw, non-bioabsorbable

The Armada spinal bone screw, a non-bioabsorbable implant used in internal spinal fixation to stabilize spinal segments for the treatment of spinal instabilities or deformities. This screw is available in various types and is typically used to provide immobilization and stabilization of the spine.

Similar devices

Also classified as Spinal bone screw, non-bioabsorbable.

4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD. · Class II
LnK/PathLoc-L MIS Spinal System — L&K BIOMED CO. , LTD. · Class II
ASPIRON™ ACPSYSTEM — CG MedTech Co., Ltd. · Class II
Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II

Cleared under the same submission

K092287 also covers:

K121619 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Nuvasive, Inc.

Sources (1)

FDA UDI 501bdfbd-751b-412e-9c44-3da6c2e53537 35 fields · synced Jul 10, 2026