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7.0 headedCCS Fully Threaded 50mm, 1/Pkg

by Medartis AG

Ref A-8417.50/1

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number76300378019PM Basic UDI-DI 07630037872535UDI-DIDate22 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630037872535 UDI-DI Date24 Feb 2023ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2361-2026 FDA Class II initiated 24 Apr 2026

    The cannulation of the CCS screw is not centered.

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  • Withdrawn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
7.0 headedCCS Fully Threaded 50mm, 1/Pkg EUDAMED
Aptus GUDID
Generic Name
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Device Name
Ccs
Model / Ref / Catalog
A-8417.50/1
Primary DI / UDI-DI
07630037872535
Basic UDI-DI
76300378019PM
510(k) Number
FDA Product Code
HWC
EMDN Code
P09120603 Cannulated screws
GMDN Term
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3040
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
CH-MF-000022291
Authorised representative
Medartis GmbH DE-AR-000005810

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Properties

  • Single Use
  • Implantable YesEUDAMEDNoGUDID
  • Sutures
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No