NexFix™ NCP System

FDA UDI

Class II (US FDA UDI)

by Tornier, Inc.

Identity

Trade Name: NexFix™ NCP System FDA UDI
Generic Name: Orthopaedic bone pin, non-bioabsorbable FDA UDI
Model / Reference: NCP-N2012 FDA UDI

Identifiers

Catalog Number: NCP-N2012 FDA UDI
Primary DI / UDI-DI: 00846832006977 FDA UDI
FDA Product Code: JDW FDA UDI
GMDN Term: Orthopaedic bone pin, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 2 Millimeter FDA UDI
Length — 12 Millimeter FDA UDI

Category: Orthopaedic bone pin, non-bioabsorbable

NexFix™ NCP System by Tornier, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthopaedic bone pin, non-bioabsorbable.

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CALIBRATED GUIDE WIRE, THREADED TROCAR POINT — Biomet Orthopedics, Inc. · Class II
TRAUMA FIXATION SYSTEMS — Biomet Orthopedics, Inc. · Class II
SMART TSF — Smith & Nephew, 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 II	Pending data

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Manufacturer

Manufacturer: Tornier, Inc.

Sources (1)

FDA UDI 96e03bb1-dc8b-43f2-9bf4-27e4c23e02a8 35 fields · synced Jun 8, 2026