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arcad® CS011416

by Novastep

Part of a family of 14 devices: see the family page

Ref CS011416

arcad® CS011416 is a device classified as Class IIb in the EU and Class II in the US made by Novastep, registered in EUDAMED on 9 Jul 2026 (Basic UDI-DI 370087950TF2B02020007T), cleared under FDA 510(k) K142111 on 19 Dec 2014 and listed in FDA GUDID since 16 Oct 2015 (UDI-DI 03700879500409), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K142111

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/MDR EUDAMED Number370087950TF2B02020007T Basic UDI-DI 03700879500409UDI-DIDate9 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700879500409 UDI-DI Date16 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK142111 Date19 Dec 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 370087950TF2B02020007T registered 9 Jul 2026 Active
  • FDA 510(k) K142111 decided 19 Dec 2014 Active
  • FDA GUDID UDI-DI 03700879500409 listed 16 Oct 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K142111
  2. Listed FDA GUDID 03700879500409
  3. Registered EUDAMED 370087950TF2B02020007T

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  • Withdrawn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
arcad®
Generic name
Surgical staple loading unit, non-cutting
Device name
Sterile compressive osteosynthesis staple
Model / Ref / Catalog
CS011416
Primary DI / UDI-DI
03700879500409
Basic UDI-DI
370087950TF2B02020007T
FDA product code
JDR
EMDN code
P09120101 Osteosynthesis staples
GMDN term
Surgical staple loading unit, non-cutting
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

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.

Related devices

Category: Surgical staple loading unit, non-cutting

Cleared under the same submission (K142111)

and 8 more cleared under K142111

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS STAPLES.

Other devices from Novastep

  • airlock® SP014014

    Class II

  • airlock® SP014016

    Class II

  • airlock® SP014018

    Class II

  • airlock® SP014022

    Class II

See all devices from Novastep →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)