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Summit Si Oct Spinal Fixation System

by Medos International SARL EUDAMEDGUDID

Active European Union

Ref 274650300Model MOUNTAINEER OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a001465Z Basic UDI-DIDate30 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10705034193090 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  • Withdrawn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
Summit Si Oct Spinal Fixation System EUDAMED
Summit GUDID
Generic Name
Manual orthopaedic bender, reusable
Device Name
Mountaineer Clamp Tap Drill Bender Feeler Torque Template
Model / Ref / Catalog
MOUNTAINEER OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER, 274650300
Primary DI / UDI-DI
10705034193090
Basic UDI-DI
0705034a001465Z
Direct Marketing DI
10705034193090
FDA Product Code
HXW
EMDN Code
L091099 Osteosynthesis instruments, reusable - other
GMDN Term
Manual orthopaedic bender, reusable
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

Related devices

Category: Surgical implant template, reusable

Other devices from Medos International SARL

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Properties

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

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: 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