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Aequalis Reversed Fracture MWD215

by Tornier, Inc.

Ref MWD215Model 08858251027964VJ

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251027964VJ Basic UDI-DI 03700386972393UDI-DIDate24 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700386972393 UDI-DI Date8 Aug 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Aequalis® Reversed Fracture EUDAMED
Aequalis Reversed Fracture GUDID
Generic Name
Bone-resection orthopaedic reamer, reusable
Device Name
Aequalis Reversed Fracture Instrumentation - Reaming Instrumentation - Class I - Reusable - Non Sterile
Model / Ref / Catalog
MWD215, 08858251027964VJ
Primary DI / UDI-DI
03700386972393
Basic UDI-DI
08858251027964VJ
Direct Marketing DI
03700386972393
FDA Product Code
HTO
EMDN Code
L091102 Orthopaedic prostheses reamers and burs, reusable
GMDN Term
Bone-resection orthopaedic reamer, reusable
Device Class
Class I
Regulation Number
888.4540
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 15 Millimeter

Related devices

Category: Bone-resection orthopaedic reamer, reusable

Other devices from Tornier, Inc.

See all devices from Tornier, Inc. →

Properties

  • Reusable
  • CMR Substance
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No