PRECICE® Instruments

FDA UDI

Class I (US FDA UDI)

by NuVasive Specialized Orthopedics, Inc.

Identity

Trade Name: PRECICE® Instruments FDA UDI
Generic Name: Orthopaedic bone-reduction tool FDA UDI
Device Name: Orthopedic surgical instrument - Fracture reducer FDA UDI
Model / Reference: FXR2-000 FDA UDI
Description: Orthopedic surgical instrument - Fracture reducer FDA UDI

Identifiers

Catalog Number: FXR2-000 FDA UDI
Primary DI / UDI-DI: 00812258028961 FDA UDI
FDA Product Code: HWN FDA UDI
GMDN Term: Orthopaedic bone-reduction tool 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

FDA UDI

Single Use

FDA UDI

Implantable

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic bone-reduction tool

PRECICE® Instruments by NuVasive Specialized Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthopaedic bone-reduction tool.

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TRIGEN — Smith & Nephew, Inc. · Class II
Reduction Rod — Double Medical Technology Inc. · Class II
MULTILOC — Synthes · Class II
TRIGEN — Smith & Nephew, Inc. · Class II
CENTRONAIL TITANIUM UNIVERSAL FEMORAL NAILING SYSTEM — Orthofix, Inc. · Class II

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 I	Pending data

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Manufacturer

Manufacturer: NuVasive Specialized Orthopedics, Inc.

Sources (1)

FDA UDI ced67cca-6ead-4947-8522-b8888d8216ee 36 fields · synced May 30, 2026