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Symphony Oct System

by Medos International SARL 701 variants

Ref 1020-35-814Model SYMPHONY OCT System - Screws

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a0023663 Basic UDI-DI 10705034518466UDI-DIDate17 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10705034518466 UDI-DI Date2 Aug 2019ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Symphony Oct System EUDAMED
Symphony GUDID
Generic name
Spinal bone screw, non-bioabsorbable
Device name
Screws for Cervical Fixation System
Model / Ref / Catalog
SYMPHONY OCT System - Screws, 1020-35-814, 102035814
Primary DI / UDI-DI
10705034518466
Basic UDI-DI
0705034a0023663
510(k) Number
FDA product code
KWP, NKG
EMDN code
P09070301 Cervical fixation systems
GMDN term
Spinal bone screw, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3050, 888.3075
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
CH-MF-000014268
Authorised representative
DePuy Ireland UC IE-AR-000009328

Related devices

Category: Cervical spine immobilization system, single-use

Other devices from Medos International SARL

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Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number

Other properties (20)

  • Supplied sterile: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No