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ADDplus

FDA UDI

Class II (US FDA UDI)

by Ulrich GmbH & Co. KG

Identity

Trade Name
ADDplus FDA UDI
Generic Name
General internal orthopaedic fixation system implantation kit FDA UDI
Device Name
Inserter for large heights FDA UDI
Model / Reference
CS 2255-2 FDA UDI
Description
Inserter for large heights FDA UDI

Identifiers

Primary DI / UDI-DI
04052536009404 FDA UDI
510(k) Number
K012254 FDA UDI
K090841 FDA UDI
K192117 FDA UDI
FDA Product Code
MQP FDA UDI
PLR FDA UDI
GMDN Term
General internal orthopaedic fixation system implantation kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3060 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

No

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: General internal orthopaedic fixation system implantation kit

ADDplus by Ulrich GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General internal orthopaedic fixation system implantation kit.

Cleared under the same submission

K012254 also covers:

K090841 also covers:

K192117 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ulrich GmbH & Co. KG

Sources (1)

  • FDA UDI d3ce3f77-b41a-4f91-a6ce-dcb0664ed4b8 35 fields · synced Jun 1, 2026