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Prostep™ Mica™ 57790003

by Wright Medical Technology, Inc.

Ref 57790003Model 08858251006864UG

Prostep™ Mica™ 57790003 is a Class I device made by Wright Medical Technology, Inc., registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI 08858251006864UG) and listed in FDA GUDID since 1 Feb 2022 (UDI-DI 00889797103626), active as of 7 Nov 2026.

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

CE MDR

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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251006864UG Basic UDI-DI 00889797103626UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889797103626 UDI-DI Date1 Feb 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251006864UG registered 27 Oct 2026 Active
  • FDA GUDID UDI-DI 00889797103626 listed 1 Feb 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00889797103626
  2. Registered EUDAMED 08858251006864UG

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  • Withdrawn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
Prostep™ Mica™
Generic name
Surgical drill guide, reusable
Device name
Prostep Mica Instrumentation - Instrumentation Sleeves - Class I - Reusable - Nonsterile
Model / Ref / Catalog
57790003, 08858251006864UG
Primary DI / UDI-DI
00889797103626
Basic UDI-DI
08858251006864UG
Direct marketing DI
00889797103626
FDA product code
LXH
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Surgical drill guide, reusable
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

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Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)