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Modulus Hip System Neck Stopper

by Limacorporate

Part of a family of 26 devices: see the family page

Ref 9043.10.370Model Modulus Hip System - Neck Stopper, 80333902A067C8

Modulus Hip System Neck Stopper (9043.10.370) is a device classified as Class I and Class IIa in the EU and Class II in the US made by Limacorporate, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-08033390112284), cleared under FDA 510(k) K151739 on 23 Nov 2015 and listed in FDA GUDID since 15 Apr 2016 (UDI-DI 08033390112284), active as of 7 Nov 2026.

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

CE MDR 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K151739

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-08033390112284 Basic UDI-DI 08033390112284UDI-DIDate6 Nov 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-08033390112284 Basic UDI-DI 08033390112284UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033390112284 UDI-DI Date15 Apr 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK151739 Date23 Nov 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08033390112284 registered 6 Nov 2026 Active· +1 more in the status table
  • FDA 510(k) K151739 decided 23 Nov 2015 Active
  • FDA GUDID UDI-DI 08033390112284 listed 15 Apr 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K151739
  2. Listed FDA GUDID 08033390112284
  3. Registered EUDAMED B-08033390112284

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Modulus Hip System - Neck Stopper EUDAMED
Modulus Hip System GUDID
Generic name
Surgical screwdriver, reusable
Model / Ref / Catalog
Modulus Hip System - Neck Stopper, 9043.10.370, 80333902A067C8, Neck Stopper
Primary DI / UDI-DI
08033390112284
Basic UDI-DI
B-08033390112284, 80333902A067C8
510(k) Number
FDA product code
LZO, LPH, KWY
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Surgical screwdriver, reusable
Device class
Class I EUDAMED
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3353, 888.3358, 888.3390
EU registration type
Legacy device (under a directive)
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
Modulus Hip System - Neck Stopper
9043.10.370
80333902A067C8
GUDID
Neck Stopper
Device classEUDAMED
Class I
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class I and Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes.

Related devices

Category: Surgical screwdriver, reusable

Cleared under the same submission (K151739)

and 8 more cleared under K151739

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Limacorporate

See all devices from Limacorporate →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)