EUDAMED last updated this device on Aug 13, 2026

PCF Monoaxial Screw

6903095SPIWGB1Z4MO6B

On the marketClass IIb

Applicable legislation: —
Organization name: Shandong Weigao Orthopaedic Device Company Limited.
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 06939488394483
Reference / catalog number: 800014034

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

PCF Monoaxial Screw is an EU-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Shandong Weigao Orthopaedic Device Company Limited.. Placed on the EU market in Lithuania. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: PCF Monoaxial Screw
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 06939488394483
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: 6903095SPIWGB1Z4MO6B
Reference / catalog number: 800014034
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: Class IIb
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)06939488394483

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

P09070301CERVICAL FIXATION SYSTEMS

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

Caution
The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient. A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where many extenuating circumstances may compromise the results. This device system is not intended to be the sole means of spinal support. Use of this product without a bone graft or in cases that develop into a non-union will not be successful. No spinal implant can withstand body loads without the support of bone. In this event, bending, loosening, disassembly and/or breakage of the device(s) will eventually occur. Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and proper selection and placement of the implants are important considerations in the successful utilization of the system by the surgeon. Further, the proper selection and compliance of the patient will greatly affect the results. Patients who smoke have been shown to have an increased incidence of non-unions. These patients should be advised of this fact and warned of this consequence. Obese, malnourished, and/or alcohol abuse patients are also poor candidates for spine fusion. Patients with poor muscle and bone quality and/or nerve paralysis are also poor candidates for spine fusion.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

Market distribution

Primary placement in Lithuania; available across 2 countries total.

Country	On market since	Until
LithuaniaPrimary placement	May 13, 2020	Nov 18, 2025
Italy	Jun 11, 2020	Nov 18, 2025

PCF Monoaxial Screw

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates covering this device

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

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