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Simple Locking Intramedullary (Slim) System Slm-40-080

by Orthopediatrics Canada ULC EUDAMEDGUDID

Active European Union

Ref SLM-40-080Model SLIM ROD

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7540194SLM-NAILSFD Basic UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07540194003294 UDI-DIDate20 Oct 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  • Withdrawn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

1 recall · FDA

    • Terminated Z-2278-2019 FDA Class II initiated 29 May 2019

    Handle could jam with the Driver due to the detachment of an internal Connector Ring.

Specification

EUDAMED · GUDID

Trade Name
The Simple Locking Intra Medullary System EUDAMED
Simple Locking Intramedullary (Slim) System GUDID
Generic Name
Arthrodesis intramedullary nail, non-distracting
Model / Ref / Catalog
SLM-40-080, SLIM ROD
Primary DI / UDI-DI
07540194003294
Basic UDI-DI
7540194SLM-NAILSFD
510(k) Number
FDA Product Code
HSB
EMDN Code
P09120201 Intramedullary nails
GMDN Term
Arthrodesis intramedullary nail, non-distracting
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3020
Market of Registration
Sweden
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 4 Millimeter
Length — 80 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Arthrodesis intramedullary nail, non-distracting

Cleared under the same submission (K143355)

Show all (12)

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Properties

  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Reusable: 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
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No