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Teardrop Rod Inserter - 145°

by Medacta International SA

Ref 03.51.10.0994

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number764014274VSR0191N00NG Basic UDI-DI 07630542777875UDI-DIDate16 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630542777875 UDI-DI Date12 Feb 2026ListedStatusListed 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  • Withdrawn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
Teardrop Rod Inserter - 145° EUDAMED
Spine Instruments GUDID
Generic Name
Orthopaedic prosthesis implantation positioning instrument, single-use
Device Name
Spine Inserter / Remover / Positioner handle and relative tool
Model / Reference
03.51.10.0994
Primary DI / UDI-DI
07630542777875
Basic UDI-DI
764014274VSR0191N00NG
Direct Marketing DI
07630542777875
FDA Product Code
LXH
EMDN Code
L091104 Orthopaedic prostheses positioners, reusable
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, single-use
Device Class
Class I
Regulation Number
888.4540
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
CH-MF-000033473
Authorised representative
Medacta Italia srl IT-AR-000022505

Other devices from Medacta International SA

See all devices from Medacta International SA →

Properties

  • Reusable
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

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