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M.U.S.T. Rods 03.50.430

by Medacta International

Ref 03.50.430Model Spine MUST rod

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K121115

FDA submission, from GUDID

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 Number764014274VIS0064R061XY Basic UDI-DI 07630030835414UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630030835414 UDI-DI Date17 Sep 2014ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK121115 Date18 Jul 2012DecidedStatusActive

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.

Recalls

1 recall · FDA

    • Terminated Z-1023-2017 FDA Class II initiated 7 Dec 2016

    Damaged packaging, lack of sterility assurance

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Rod CoCr 5.5 x 100mm - Sterile EUDAMED
M.U.S.T. Rods GUDID
Generic name
Bone-screw internal spinal fixation system rod
Model / reference
03.50.430, Spine MUST rod
Primary DI / UDI-DI
07630030835414
Basic UDI-DI
764014274VIS0064R061XY
510(k) Number
FDA product code
KWP, KWQ, NKB, MNH, MNI
EMDN code
P09070302 Thoracolumbosacral fixation systems
GMDN term
Bone-screw internal spinal fixation system rod
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3050, 888.3060, 888.3070
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Bone-screw internal spinal fixation system rod

Cleared under the same submission (K121115)

Show all (12)

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (18)

  • Sterilise before use: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No