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Tornier Latitude

FDA UDI

Class I (US FDA UDI)

by Tornier, Inc.

Identity

Trade Name
Tornier Latitude FDA UDI
Generic Name
Orthopaedic implant/instrument assembling device FDA UDI
Device Name
CRIMPING CLAMP - HUMERAL SCREW FDA UDI
Model / Reference
MKY133 FDA UDI
Description
CRIMPING CLAMP - HUMERAL SCREW FDA UDI

Identifiers

Catalog Number
MKY133 FDA UDI
Primary DI / UDI-DI
00846832013524 FDA UDI
FDA Product Code
HXD FDA UDI
GMDN Term
Orthopaedic implant/instrument assembling device 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic implant/instrument assembling device

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

Similar devices

Also classified as Orthopaedic implant/instrument assembling device.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tornier, Inc.

Sources (1)

  • FDA UDI 795c03e5-7b23-43a8-a8f0-6c85631f53eb 35 fields · synced Jun 1, 2026