Compression Staple System

FDA UDI

Class I (US FDA UDI)

by Tornier, Inc.

Identity

Trade Name: Compression Staple System FDA UDI
Generic Name: Surgical drill guide, reusable FDA UDI
Device Name: DRILL GUIDE TIP FDA UDI
Model / Reference: STP-171-2819 FDA UDI
Description: DRILL GUIDE TIP FDA UDI

Identifiers

Catalog Number: STP-171-2819 FDA UDI
Primary DI / UDI-DI: 00846832056149 FDA UDI
FDA Product Code: FZX FDA UDI
GMDN Term: Surgical drill guide, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 2.8 Millimeter FDA UDI
Length — 19 Millimeter FDA UDI

Category: Surgical drill guide, reusable

Compression Staple System by Tornier, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Legion — Smith & Nephew, Inc. · Class II
Hintermann Series — Dt Medtech, LLC · Class I

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: Tornier, Inc.

Sources (1)

FDA UDI 8b57ef04-1d45-4184-885e-036f01312a2a 36 fields · synced May 30, 2026