Conklusion

FDA UDI

Class II (US FDA UDI)

by SIGNUS Medizintechnik GmbH

Identity

Trade Name: CONKLUSION FDA UDI
Generic Name: Spinal bone set screw FDA UDI
Device Name: The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, screws, rods, connectors, and associated instruments. Fixation is provided by bone (pedicular) screws inserted into the vertebral body of the spine using posterior approach. FDA UDI
Model / Reference: Locking screw FDA UDI
Description: The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, screws, rods, connectors, and associated instruments. Fixation is provided by bone (pedicular) screws inserted into the vertebral body of the spine using posterior approach. FDA UDI

Identifiers

Catalog Number: 100000 FDA UDI
Primary DI / UDI-DI: 04047844013526 FDA UDI
FDA Product Code: MNI FDA UDI
MNH FDA UDI
GMDN Term: Spinal bone set screw FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Spinal bone set screw

Conklusion by SIGNUS Medizintechnik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Vertefix II — ELITE SURGICAL SUPPLIES (PTY) LTD · 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: SIGNUS Medizintechnik GmbH

Sources (1)

FDA UDI 0cdc8ed7-a6ad-4165-8353-a81bb871dd80 37 fields · synced May 30, 2026