Skip to content

Prostep Mica 57S100MT

by Wright Medical Technology, Inc.

Ref 57S100MTModel 08858251007096TU

Prostep Mica 57S100MT is a device classified as Class IIa in the EU and Class I in the US made by Wright Medical Technology, Inc., registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI 08858251007096TU) and listed in FDA GUDID since 12 Aug 2022 (UDI-DI 00889797071994), 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 Number08858251007096TU Basic UDI-DI 00889797071994UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889797071994 UDI-DI Date12 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251007096TU registered 26 Oct 2026 Active
  • FDA GUDID UDI-DI 00889797071994 listed 12 Aug 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00889797071994
  2. Registered EUDAMED 08858251007096TU

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  • Withdrawn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® EUDAMED
Prostep Mica GUDID
Generic name
Orthopaedic osteotome
Device name
PROSTEP MICA SCREWS INSTRUMENTATION-BONE SURFACE PREPARATION INSTRUMENTATION- Class lla- STERILE
Model / Ref / Catalog
57S100MT, 08858251007096TU
Primary DI / UDI-DI
00889797071994
Basic UDI-DI
08858251007096TU
FDA product code
HTJ
EMDN code
P091399 Orthopaedic implant instruments, single-use - other
GMDN term
Orthopaedic osteotome
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4300
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthopaedic osteotome

Similar devices in this category

Other devices filed under ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from Wright Medical Technology, Inc.

See all devices from Wright Medical Technology, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)