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Aptus A-2811

by Medartis Inc.

Ref A-2811

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number07630894829000 UDI-DI Date16 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number76300378011P5 Basic UDI-DI 07630894829000UDI-DIDate13 Apr 2026RegisteredStatusActive

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

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

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  • Withdrawn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
2.8 Screwdriver Blade, L145mm, HD7, AO EUDAMED
Aptus GUDID
Generic Name
General internal orthopaedic fixation system implantation kit
Device Name
Blades (not connected to an active device)
Model / Ref / Catalog
A-2811
Primary DI / UDI-DI
07630894829000
Basic UDI-DI
76300378011P5
510(k) Number
FDA Product Code
LXH
EMDN Code
L99 Surgical instruments, reusable - other
GMDN Term
General internal orthopaedic fixation system implantation kit
Device Class
Class I
Regulation Number
888.4540
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K260761)

Show all (12)

Other devices from Medartis Inc.

See all devices from Medartis Inc. →

Properties

  • Reusable
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No