PRECICE® Intramedullary Limb Lengthening System

FDA UDI

Class II (US FDA UDI)

by NuVasive Specialized Orthopedics, Inc.

Identity

Trade Name: PRECICE® Intramedullary Limb Lengthening System FDA UDI
Generic Name: Tibia intramedullary nail FDA UDI
Device Name: Orthopedic intramedullary limb lengthening rod, antegrade tibia, 12.5 mm diameter, 335 mm length FDA UDI
Model / Reference: PR12.5-80C335 FDA UDI
Description: Orthopedic intramedullary limb lengthening rod, antegrade tibia, 12.5 mm diameter, 335 mm length FDA UDI

Identifiers

Catalog Number: PR12.5-80C335 FDA UDI
Primary DI / UDI-DI: 00812258025175 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 12.5 Millimeter FDA UDI

Category: Tibia intramedullary nail

PRECICE® Intramedullary Limb Lengthening System by NuVasive Specialized Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID

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 247ad500-6cce-4ba2-96ce-d093b6b54b4d 36 fields · synced May 31, 2026