PRECICE® Instruments

FDA UDI

Class II (US FDA UDI)

by NuVasive Specialized Orthopedics, Inc.

Identity

Trade Name: PRECICE® Instruments FDA UDI
Generic Name: Tibia intramedullary nail FDA UDI
Device Name: Orthopedic surgical instrument - Targeting Arm Tibia, PRECICE FDA UDI
Model / Reference: PGA1-000 FDA UDI
Description: Orthopedic surgical instrument - Targeting Arm Tibia, PRECICE FDA UDI

Identifiers

Catalog Number: PGA1-000 FDA UDI
Primary DI / UDI-DI: 00887517001115 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Tibia intramedullary nail FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3020 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

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

MRI Safety

MR Unsafe FDA UDI

Category: Tibia intramedullary nail

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

Similar devices

Also classified as Tibia intramedullary nail.

Natural Nail® — Zimmer, Inc. · Class II
Affixus® — Zimmer, Inc. · Class II
Affixus® — Zimmer, Inc. · Class II
TRIGEN MAX — Smith & Nephew, Inc. · Class II
Piccolo Composite Nailing System — CARBOFIX ORTHOPEDICS LTD · Class II
AJAX Nail — Auxein Medical Private Limited · Class II
ESTREMO — Citieffe · Class II
PNP Tibia — ORTHOPEDIATRICS CORP. · 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 II	Pending data

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Manufacturer

Manufacturer: NuVasive Specialized Orthopedics, Inc.

Sources (1)

FDA UDI c72e76be-0bd4-479b-9789-6bfd7e13d460 36 fields · synced May 30, 2026