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Dinamic T Humerus

by Citieffe 5 variants

Part of a family of 23 devices: see the family page

Ref DT070037Model HAND DRILL BITS

Dinamic T Humerus (DT070037) is a device classified as Class I in the EU and Class II in the US made by Citieffe, registered in EUDAMED on 9 Sep 2026 (Basic UDI-DI 803290962135BZ), cleared under FDA 510(k) K113387 on 15 Mar 2012 and listed in FDA GUDID since 15 Dec 2018 (UDI-DI 08051739534122), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K113387

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number803290962135BZ Basic UDI-DI 08051739534122UDI-DIDate9 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08051739534122 UDI-DI Date15 Dec 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK113387 Date15 Mar 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 803290962135BZ registered 9 Sep 2026 Active
  • FDA 510(k) K113387 decided 15 Mar 2012 Active
  • FDA GUDID UDI-DI 08051739534122 listed 15 Dec 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K113387
  2. Listed FDA GUDID 08051739534122
  3. Registered EUDAMED 803290962135BZ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Strumenti Chirurgici (Ir) EUDAMED
Dinamic T Humerus GUDID
Generic name
Medullary canal orthopaedic reamer, rigid
Device name
Surgical Instruments (Ir)
Model / Ref / Catalog
HAND DRILL BITS, DT070037, Cannulated drill bit, ø5mm, Hudson connection
Primary DI / UDI-DI
08051739534122
Basic UDI-DI
803290962135BZ
Direct marketing DI
08051739534122
510(k) Number
FDA product code
HSB
EMDN code
L0916 Orthopaedic surgery burs and tips, reusable
GMDN term
Medullary canal orthopaedic reamer, rigid
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3020
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
HAND DRILL BITS
DT070037
GUDID
Cannulated drill bit,ø5mm, Hudson connection
Device classEUDAMED
Class I
GUDID
Class II

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

Related devices

Category: Medullary canal orthopaedic reamer, rigid

Cleared under the same submission (K113387)

and 8 more cleared under K113387

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE.

Other devices from Citieffe

See all devices from Citieffe →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)