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10011

by Innovate Orthopaedics

Ref 10011

10011 is a device classified as Class IIb in the EU and Class II in the US made by Innovate Orthopaedics, Ltd., registered in EUDAMED on 24 Jan 2023 (Basic UDI-DI B-05060464140112) and listed in FDA GUDID since 15 Jul 2022 (UDI-DI 05060464140112), active as of 24 Oct 2026.

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

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05060464140112 Basic UDI-DI 05060464140112UDI-DIDate24 Jan 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number05060464140112 UDI-DI Date15 Jul 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-05060464140112 registered 24 Jan 2023 Active
  • FDA GUDID UDI-DI 05060464140112 listed 15 Jul 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05060464140112
  2. Registered EUDAMED B-05060464140112

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Quick-Start
Generic name
Orthopaedic bone screw (non-sliding)
Model / Ref / Catalog
10011
Primary DI / UDI-DI
05060464140112
Basic UDI-DI
B-05060464140112
FDA product code
HWC
EMDN code
P09120605 Interference screws
GMDN term
Orthopaedic bone screw (non-sliding)
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Legacy device (under a directive)
EU market of registration
Northern Ireland
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.

Manufacturer details

EUDAMED SRN
GB-MF-000012886
Authorised representative
Acorn Regulatory Consultancy Services Ltd IE-AR-000000592

Related devices

Category: Tendon/ligament bone anchor, non-bioabsorbable

Similar devices in this category

Other devices filed under INTERFERENCE SCREWS.

Other devices from Innovate Orthopaedics, Ltd.

  • 10001

    Class IIb

  • 10007

    Class IIb

  • 10005

    Class IIb

  • 10003

    Class IIb

See all devices from Innovate Orthopaedics, Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)