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Flexible Reamers System 1

by Orthofix SRL 7 variants

Ref 172002CModel Procedure Pack for internal fixation

Flexible Reamers System 1 (172002C) is a device classified as Class IIa in the EU and Class I in the US made by Orthofix SRL, registered in EUDAMED on 3 Aug 2026 (Basic UDI-DI 805050436PPckInInst2aNA2U) and listed in FDA GUDID since 23 Jul 2026 (UDI-DI 18059015378399), active as of 12 Nov 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805050436PPckInInst2aNA2U Basic UDI-DI 18059015378399UDI-DIDate3 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18059015378399 UDI-DI Date23 Jul 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 805050436PPckInInst2aNA2U registered 3 Aug 2026 Active
  • FDA GUDID UDI-DI 18059015378399 listed 23 Jul 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 18059015378399
  2. Registered EUDAMED 805050436PPckInInst2aNA2U

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  • Withdrawn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
Flexible Reamer EUDAMED
Flexible Reamers System GUDID
Generic name
General internal orthopaedic fixation system implantation kit
Model / Ref / Catalog
Procedure Pack for internal fixation, 172002C, 1
Primary DI / UDI-DI
18059015378399
Basic UDI-DI
805050436PPckInInst2aNA2U
FDA product code
HTO
EMDN code
V0599 Clinical procedures kits not included in other classes - other
GMDN term
General internal orthopaedic fixation system implantation kit
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
System or procedure pack
Procedure pack
EU registration type
System or procedure pack
Medical purpose
Instrumentation for surgical application of internal fixation devices
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Procedure Pack for internal fixation
172002C
GUDID
1
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Similar devices in this category

Other devices filed under CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER.

Other devices from Orthofix SRL

See all devices from Orthofix SRL →

Properties

  • Sterilise before use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)