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Xlif

FDA UDI

Class I (US FDA UDI)

by Nuvasive, Inc.

Identity

Trade Name
XLIF FDA UDI
Generic Name
Orthopaedic stereotactic surgery system FDA UDI
Device Name
Prone Positioner Bolster, Universal FDA UDI
Model / Reference
1100002 FDA UDI
Description
Prone Positioner Bolster, Universal FDA UDI

Identifiers

Primary DI / UDI-DI
00195377161017 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic stereotactic surgery system FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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

Yes

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
Radiation Sterilization FDA UDI

Category: Orthopaedic stereotactic surgery system

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

Similar devices

Also classified as Orthopaedic stereotactic surgery system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nuvasive, Inc.

Sources (1)

  • FDA UDI e7fc4e45-8898-4ba1-9960-7891f09fe450 34 fields · synced May 30, 2026