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NuVasive

FDA UDI

Class II (US FDA UDI)

by Nuvasive, Inc.

Identity

Trade Name
NuVasive FDA UDI
Generic Name
Spinal implant trial FDA UDI
Device Name
TLX Paddle Sizer - 8mm FDA UDI
Model / Reference
Z500113-08 FDA UDI
Description
TLX Paddle Sizer - 8mm FDA UDI

Identifiers

Primary DI / UDI-DI
00887517949974 FDA UDI
510(k) Number
K171633 FDA UDI
FDA Product Code
PHM FDA UDI
MAX FDA UDI
GMDN Term
Spinal implant trial 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

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

No

FDA UDI

Lot / Batch Number

No

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: Spinal implant trial

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

Similar devices

Also classified as Spinal implant trial.

Cleared under the same submission

K171633 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 90277393-8b68-4302-be8f-9ef6f0f2149b 35 fields · synced May 30, 2026