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Dyna Locking Trochanteric Nail™

by CG MedTech Co., Ltd. 184 variants

Ref NGA2105

Dyna Locking Trochanteric Nail™ (NGA2105) is a device classified as Class IIb in the EU and Class II in the US made by CG MedTech Co., Ltd., registered in EUDAMED on 6 Mar 2026 (Basic UDI-DI B-08800015918077), cleared under FDA 510(k) K093707 on 23 Jun 2010 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 08800015918077), active as of 22 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K093707

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800015918077 Basic UDI-DI 08800015918077UDI-DIDate6 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800015918077 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK093707 Date23 Jun 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800015918077 registered 6 Mar 2026 Active
  • FDA 510(k) K093707 decided 23 Jun 2010 Active
  • FDA GUDID UDI-DI 08800015918077 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K093707
  2. Listed FDA GUDID 08800015918077
  3. Registered EUDAMED B-08800015918077

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Femoral neck fixation sliding bone screw
Device name
NECK SCREW ASSEMBLY – 105 mm
Model / reference
NGA2105
Primary DI / UDI-DI
08800015918077
Basic UDI-DI
B-08800015918077
510(k) Number
FDA product code
HSB
EMDN code
P09120201 Intramedullary nails
GMDN term
Femoral neck fixation sliding bone screw
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3020
EU registration type
Legacy device (under a directive)
EU market of registration
Greece
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
KR-MF-000035461
Authorised representative
Obelis s.a. BE-AR-000000106

Related devices

Category: Arthrodesis intramedullary nail, non-distracting

Similar devices in this category

Other devices filed under INTRAMEDULLARY NAILS.

Other devices from CG MedTech Co., Ltd.

See all devices from CG MedTech Co., Ltd. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Serial number
Other properties (17, all answered No)