Apx

FDA UDI

Class II (US FDA UDI)

by Nuvasive, Inc.

Identity

Trade Name: APX FDA UDI
Generic Name: Vertebral body prosthesis FDA UDI
Device Name: XLIF APX, 10X30X55mm 0° FDA UDI
Model / Reference: 1672355 FDA UDI
Description: XLIF APX, 10X30X55mm 0° FDA UDI

Identifiers

Primary DI / UDI-DI: 00887517184757 FDA UDI
510(k) Number: K130820 FDA UDI
K140162 FDA UDI
K140770 FDA UDI
K151374 FDA UDI
K153105 FDA UDI
K173025 FDA UDI
FDA Product Code: MAX FDA UDI
PHM FDA UDI
GMDN Term: Vertebral body prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Vertebral body prosthesis

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

Similar devices

Also classified as Vertebral body prosthesis.

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FORTIFY — GLOBUS MEDICAL, INC. · Class II
VERTE-STACK® Spinal System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
CASCADIA™ Interbody System — K2M, INC. · Class II
CAPRI™ Corpectomy Cage System — K2M, INC. · Class II
Cascadia™ Interbody System — K2M, INC. · Class II

Cleared under the same submission

K130820 also covers:

K140162 also covers:

K140770 also covers:

K151374 also covers:

K153105 also covers:

K173025 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 a327f226-00f2-40f8-88f5-ceabe1fcb01a 35 fields · synced Jun 8, 2026