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P09120501

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 153.08

by Fixier Sa De Cv

Identity

Trade Name
P09120501 EUDAMED
Traufix osteosynthesis, osteotomy, and arthrodesis devices FDA UDI
Generic Name
Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Device Name
Placa ALP para tibia proximal OPTIMUS izquierda titanio 8 orificios EUDAMED
ALP titanium proximal tibia plate OPTIMUS 8 holes left FDA UDI
Model / Reference
153.08 EUDAMEDFDA UDI
Description
ALP titanium proximal tibia plate OPTIMUS 8 holes left FDA UDI

Identifiers

Catalog Number
153.08 FDA UDI
Primary DI / UDI-DI
07506494214990 EUDAMEDFDA UDI
Basic UDI-DI
B-07506494214990 EUDAMED
510(k) Number
K201510 FDA UDI
FDA Product Code
HRS FDA UDI
EMDN Code
P09120501 OSTEOSYNTHESIS COMPRESSION PLATES EUDAMED
GMDN Term
Orthopaedic fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
Market of Registration
Spain EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

P09120501 by Fixier Sa De Cv — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fixier Sa De Cv
EUDAMED SRN
MX-MF-000031017
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (2)

  • EUDAMED 06aad68f-a938-467a-8300-a5832bd0e9f7 61 fields · synced Jul 23, 2026
  • FDA UDI 50a023ea-b85b-49a3-8ddd-2a135f59af32 36 fields · synced May 30, 2026