Symphony Oct System

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 1020-40-310SModel SYMPHONY OCT System - Screws

by Medos International SARL

Identity

Trade Name: SYMPHONY OCT SYSTEM EUDAMED
SYMPHONY FDA UDI
Generic Name: Spinal bone screw, non-bioabsorbable FDA UDI
Device Name: Screws for Cervical Fixation System EUDAMED
SYMPHONY OCT SYSTEM POLYAXIAL SCREW REDUCTION CANNULATED Diameter 4.0 Rod, 4.0X10mm 3.5 4.0 FDA UDI
Model / Reference: SYMPHONY OCT System - Screws EUDAMED
1020-40-310S EUDAMEDFDA UDI
Description: SYMPHONY OCT SYSTEM POLYAXIAL SCREW REDUCTION CANNULATED Diameter 4.0 Rod, 4.0X10mm 3.5 4.0 FDA UDI

Identifiers

Catalog Number: 102040310S FDA UDI
Primary DI / UDI-DI: 10705034528946 EUDAMEDFDA UDI
Basic UDI-DI: 0705034a0023663 EUDAMED
510(k) Number: K192646 FDA UDI
FDA Product Code: NKG FDA UDI
KWP FDA UDI
EMDN Code: P09070301 CERVICAL FIXATION SYSTEMS EUDAMED
GMDN Term: Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 888.3075 FDA UDI
888.3050 FDA UDI
Market of Registration: Belgium EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Sutures

Yes

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Cervical spine immobilization system, single-use

The SYMPHONY OCT SYSTEM, a cutting-edge surgical instrument designed for cervical fixation, offers unparalleled precision and accuracy in minimally invasive procedures. With its advanced technology and innovative design, this device has revolutionized the field of orthopedic surgery.

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	0705034a0023663	Class IIb	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIb	Pending data

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Manufacturer

Manufacturer: Medos International SARL
EUDAMED SRN: CH-MF-000014268
Authorised Representative: DePuy Ireland UC IE-AR-000009328

Sources (2)

EUDAMED 67c03f1d-0edc-4733-992d-a078a53e99da 61 fields · synced Jul 26, 2026
FDA UDI 109a8bc3-d565-492e-9468-1755a30e4479 36 fields · synced May 30, 2026

Symphony Oct System

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Authorization Coverage (2 countries)

Regulatory Authorizations

Manufacturer

Sources (2)