NuVasive

FDA UDI

Class II (US FDA UDI)

by Nuvasive, Inc.

Identity

Trade Name: NuVasive FDA UDI
Generic Name: External spinal fixation system FDA UDI
Device Name: Universal Probe, Ball-Tip FDA UDI
Model / Reference: 7200028 FDA UDI
Description: Universal Probe, Ball-Tip FDA UDI

Identifiers

Primary DI / UDI-DI: 00887517428998 FDA UDI
510(k) Number: K112709 FDA UDI
FDA Product Code: ETN FDA UDI
GMDN Term: External spinal fixation system 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

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: External spinal fixation system

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

Similar devices

Also classified as External spinal fixation system.

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King Cobra — EMINENT SPINE LLC · Class II
King Cobra — EMINENT SPINE LLC · Class II
4CIS® INSTRUMENT SYSTEM — ALPHANOX CO., LTD. · Class I
Fang Plate — EMINENT SPINE LLC · Class II
30 deg Offset Impactor — Koros USA, Inc. · Class II
4CIS® INSTRUMENT SYSTEM — ALPHANOX CO., LTD. · Class I

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 f43ac6da-cc5e-4ce9-a008-e676ad679280 35 fields · synced May 30, 2026