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EUDAMED last updated this device on Apr 30, 2026
B-08680487052383Distal Lateral Fibular Locking Plate Right 4 Holes is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by NORMMED MEDİKAL SAN. VE TİC. A.Ş.. Placed on the EU market in Türkiye. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08680487052383PNM1016-104TR-MF-000015713M.2016.106.6594(01)08680487052383
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Türkiye; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| TürkiyePrimary placement | Apr 12, 2016 | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
P09120503OSTEOSYNTHESIS SCREW-PLATE SYSTEMSPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →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 →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 →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
View in glossary →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 →No certificate specifically references this device's Basic UDI-DI.
B-08680487047228On the marketDistal Lateral Fibular Locking Plate Right 12 HolesB-08680487052451On the marketDistal Lateral Fibular Locking Plate Right 14 HolesB-08680487052468On the marketDistal Lateral Fibular Locking Plate Right 5 HolesB-08680487052390On the marketDistal Lateral Fibular Locking Plate Right 6 HolesB-08680487052406On the marketDistal Lateral Fibular Locking Plate Right 7 HolesB-08680487052413On the marketCertificate health across this manufacturer's portfolio.
MDR.2292-2026/0042IssuedMDR.2292-2024/0001SupplementedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →