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Ultrafix

by Conmed Corporation

Part of a family of 12 devices: see the family pagePart of a family of 28 devices: see the family page

Ref 10053, 10085, 10095A, 10121, 10004A, 10202

Ultrafix (10053) is a device classified as Class I and Class IIa in the EU made by Conmed Corporation, registered in EUDAMED on 21 Oct 2025 (Basic UDI-DI 084585408521D5) and listed in FDA GUDID since 24 Sep 2020 (UDI-DI 10845854037041), active as of 24 Oct 2026.

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

CE MDR 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 Number084585408521D5 Basic UDI-DI Date21 Oct 2025RegisteredStatusActive
European UnionCE/MDR EUDAMED Number084585408521D5 Basic UDI-DI Date21 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10845854037041 UDI-DI Date24 Sep 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 084585408521D5 registered 21 Oct 2025 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10845854037041 listed 24 Sep 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10845854037041
  2. Registered EUDAMED 084585408521D5

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Orthopaedic implant driver
Fluted surgical drill bit, reusable
Instrument tray, reusable
Surgical drill guide, reusable
Device name
Orthopedic, Non-active, Instrument Tray
Orthopedic, Non-active, Reusable Surgical Instrument, Passing/Retrieval
Powered Surgical Instruments
Model / Ref / Catalog
10053, 10085, 10095A, 10121, 10004A, 10202
Primary DI / UDI-DI
10845854037041, 10845854037058, 10845854037072, 10845854024195, 10845854037010, 10845854037102
Basic UDI-DI
084585408521D5, 084585408435DB, B-10845854037072, B-10845854037010, B-10845854037102
Direct marketing DI
20845854037048
20845854037055
20845854024192
FDA product code
LXH, GFG, FSM, MDM
EMDN code
S010401, L091001, L0922, L0916
GMDN term
Orthopaedic implant driver
Fluted surgical drill bit, reusable
Instrument tray, reusable
Surgical drill guide, reusable
Device class
Class I EUDAMEDGUDID
Class IIa EUDAMED
Regulation number
888.4540, 878.4820, 878.4800
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 2.4 Millimeter

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
Class IIa
GUDID
Class I
Supplied sterileEUDAMED
No
Yes
GUDID
No
Sterilise before useEUDAMED
No
Yes
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Supplied sterile UDI-DI 10845854037072: EUDAMED states Yes, FDA GUDID states No.
  • Supplied sterile UDI-DI 10845854037010: EUDAMED states Yes, FDA GUDID states No.
  • Sterilise before use UDI-DI 10845854037041: EUDAMED states No, FDA GUDID states Yes.
  • Sterilise before use UDI-DI 10845854037072: EUDAMED states No, FDA GUDID states Yes.
  • Sterilise before use UDI-DI 10845854037010: EUDAMED states No, FDA GUDID states Yes.

Manufacturer details

EUDAMED SRN
US-MF-000012663
Authorised representative
MDSS GmbH DE-AR-000005430

Related devices

Category: Instrument tray, reusable

Similar devices in this category

Other devices filed under INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE.

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties

  • Supplied sterile NoEUDAMEDGUDIDYesEUDAMED
  • Sterilise before use NoEUDAMEDYesEUDAMEDGUDID
  • Reusable NoEUDAMEDYesEUDAMED
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)