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Aptus A-4850.68

by Medartis Inc.

Ref A-4850.68

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

2 ongoing

Recall on shared 510(k) K091479; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K091479

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number76300378020P6 Basic UDI-DI 07630037895107UDI-DIDate25 Mar 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07630037895107 UDI-DI Date24 Feb 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK091479 Date13 Jul 2009DecidedStatusActive

Official records

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

2 recalls · 2 ongoing · FDA

    • Ongoing Z-1550-2026 FDA Class II initiated 9 Jan 2026 on shared 510(k) K091479

    Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.

    • Ongoing Z-1821-2024 FDA Class II initiated 12 Apr 2024 on shared 510(k) K091479

    Screw is 16mm long instead of 22mm long.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
2.8 TriLock Grid Pl 3+3 Hole, 32mm, t1.6 EUDAMED
Aptus GUDID
Generic name
Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Device name
Bone plates (sterile, non-sterile)
Model / Ref / Catalog
A-4850.68
Primary DI / UDI-DI
07630037895107
Basic UDI-DI
76300378020P6
510(k) Number
FDA product code
HRS
EMDN code
P09120599 Bone fixation plates - other
GMDN term
Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation 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

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Cleared under the same submission (K091479)

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Properties

  • Sterilise before use
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Sutures
  • Prescription use
  • Lot / batch number
  • Manufacturing date

Other properties (19)

  • Supplied sterile: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No