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StruXure

FDA UDI

Class II (US FDA UDI)

by Nuvasive, Inc.

Identity

Trade Name
StruXure FDA UDI
Generic Name
Fascial tissue dilator, reusable FDA UDI
Device Name
StruXure Dilator, Fixation FDA UDI
Model / Reference
1656600 FDA UDI
Description
StruXure Dilator, Fixation FDA UDI

Identifiers

Primary DI / UDI-DI
00887517184702 FDA UDI
510(k) Number
K112709 FDA UDI
FDA Product Code
ETN FDA UDI
GMDN Term
Fascial tissue dilator, reusable 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

No

FDA UDI

Single Use

Yes

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

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: Fascial tissue dilator, reusable

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

Similar devices

Also classified as Fascial tissue dilator, reusable.

Cleared under the same submission

K112709 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 258688d9-ce89-460d-9d86-3a1bf8d09a10 35 fields · synced Jun 8, 2026