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Saber Lumbar I/F Cage System

by Medos International SARL EUDAMEDGUDID 6 variants

Active European Union

Ref 287001008Model Concorde Bullet Instruments for Insertion and Extraction

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a000796B Basic UDI-DIDate15 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10705034215617 UDI-DIDate31 Dec 2016ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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 on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Saber Lumbar I/F Cage System EUDAMED
Saber Lumbar I/F Cage GUDID
Generic Name
Orthopaedic implantable-device cutter
Device Name
Concorde Bullet Trial Spacer Funnel Impactor Inserter Disc Shaver
Model / Ref / Catalog
Concorde Bullet Instruments for Insertion and Extraction, 287001008
Primary DI / UDI-DI
10705034215617
Basic UDI-DI
0705034a000796B
Direct Marketing DI
10705034215617
FDA Product Code
LXH
EMDN Code
L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
GMDN Term
Orthopaedic implantable-device cutter
Device Class
Class I
Regulation Number
888.4540
Market of Registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Manufacturer details

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

Other devices from Medos International SARL

See all devices from Medos International SARL →

Properties

  • Reusable
  • CMR Substance
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No