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Apx

FDA UDI

Class II (US FDA UDI)

by Nuvasive, Inc.

Identity

Trade Name
APX FDA UDI
Generic Name
External spinal fixation system FDA UDI
Device Name
XLIF APX Rod, 30x55mm FDA UDI
Model / Reference
1632887 FDA UDI
Description
XLIF APX Rod, 30x55mm FDA UDI

Identifiers

Primary DI / UDI-DI
00887517211019 FDA UDI
510(k) Number
K140162 FDA UDI
FDA Product Code
MAX FDA UDI
GMDN Term
External spinal fixation system 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

No

FDA UDI

Single Use

No

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

Category: External spinal fixation system

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

Similar devices

Also classified as External spinal fixation system.

Cleared under the same submission

K140162 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nuvasive, Inc.

Sources (1)

  • FDA UDI bc781f5a-8620-451c-89f1-1da90dbcac68 35 fields · synced May 30, 2026