Made-To-Order

FDA UDI

Class I (US FDA UDI)

by Tornier, Inc.

Identity

Trade Name: Made-To-Order FDA UDI
Generic Name: Surgical implant template, reusable FDA UDI
Device Name: Simpliciti Trial Head FDA UDI
Model / Reference: 9027501 FDA UDI
Description: Simpliciti Trial Head FDA UDI

Identifiers

Catalog Number: 9027501 FDA UDI
Primary DI / UDI-DI: 00846832097609 FDA UDI
FDA Product Code: HWT FDA UDI
GMDN Term: Surgical implant template, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4800 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

Category: Surgical implant template, reusable

Made-To-Order by Tornier, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 f36ce977-78fa-4115-99c6-947d579387c8 36 fields · synced May 31, 2026