Skip to content

HeadCannCompScrew 3.0mm HL3021

by Trimed, INC.

Ref HL3021Model Screws

HeadCannCompScrew 3.0mm HL3021 is a device classified as Class IIb in the EU and Class II in the US made by Trimed, INC., registered in EUDAMED on 23 Sep 2026 (Basic UDI-DI 08421881SCREWM7) with CE/MDR certificate US25/00000499 valid until 27 Nov 2030, cleared under FDA 510(k) K243943 on 10 Apr 2025 and listed in FDA GUDID since 7 Sep 2016 (UDI-DI 00842188104312), active as of 2 Nov 2026.

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

CE MDR 510(k)

Valid until

27 Nov 2030

CE MDR certificate

FDA recalls

None found

in data synced 2 Nov 2026

Documents

2 certificates

Certifier SGS Belgium NV

510(k) K243943

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 2 Nov 2026.

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberUS25/00000499 Date23 Sep 2026IssuedStatusActive expires 27 Nov 2030
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK243943 Date10 Apr 2025DecidedStatusActive
United StatesGUDID listing GUDID Number00842188104312 UDI-DI Date7 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08421881SCREWM7 registered 23 Sep 2026 Active· +1 more in the status table
  • FDA 510(k) K243943 decided 10 Apr 2025 Active
  • FDA GUDID UDI-DI 00842188104312 listed 7 Sep 2016 Listed

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • US25/00000499 Active Removed from EUDAMED

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    27 Nov 2025
    Expires
    27 Nov 2030
  • US25/00000499 Active Supplemented

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    23 Sep 2026
    Expires
    27 Nov 2030
    Reason
    Add device or group

Timeline

5 dated events

  1. Listed FDA GUDID 00842188104312
  2. Cleared FDA 510(k) K243943
  3. Certificate issued EUDAMED US25/00000499
  4. Registered EUDAMED 08421881SCREWM7
  5. Certificate expires EUDAMED US25/00000499

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
Compression Screws EUDAMED
HeadCannCompScrew 3.0mm GUDID
Generic name
Orthopaedic bone screw (non-sliding)
Model / Ref / Catalog
HL3021, Screws
Primary DI / UDI-DI
00842188104312
Basic UDI-DI
08421881SCREWM7
510(k) Number
FDA product code
HWC
EMDN code
P09120603 Cannulated screws
GMDN term
Orthopaedic bone screw (non-sliding)
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Orthopaedic bone screw (non-sliding)

Cleared under the same submission (K050681)

and 8 more cleared under K050681

Cleared under the same submission (K243943)

and 8 more cleared under K243943

Other devices from Trimed, INC.

See all devices from Trimed, INC. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)