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Orthofix Modulsystem 1

by Orthofix, Inc. 319 variants

Ref 943570Model BONE FIXATION SCREWS, TENDONS AND LIGAMENTS SCREWS

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

23 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805050436Screw2bNAC26D3P Basic UDI-DI 18054242515968UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18054242515968 UDI-DI Date16 Sep 2016ListedStatusListed 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.

Recalls

23 recalls · FDA

  • 21 recalls, same reason

    • Terminated Z-0390-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0375-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0382-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0383-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0374-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0373-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0393-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0379-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0391-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0384-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0381-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0392-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0377-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0378-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0387-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0386-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0385-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0376-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0380-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0388-2020 FDA Class II initiated 27 Sep 2018
    • Terminated Z-0389-2020 FDA Class II initiated 27 Sep 2018

    As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.

  • 2 recalls, same reason

    • Terminated Z-1435-2010 FDA Unclassified (pre-2012) initiated 22 Feb 2010
    • Terminated Z-1434-2010 FDA Unclassified (pre-2012) initiated 22 Feb 2010

    During standard quality controls, firm identified a potential for breakage of the XCaliber clamp when locking the cam.

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
Implantable Devices for External Fixation and Related Instruments EUDAMED
Orthofix Modulsystem GUDID
Generic Name
Orthopaedic bone screw (non-sliding)
Model / Ref / Catalog
BONE FIXATION SCREWS, TENDONS AND LIGAMENTS SCREWS, 943570, 1
Primary DI / UDI-DI
18054242515968
Basic UDI-DI
805050436Screw2bNAC26D3P
510(k) Number
FDA Product Code
JDW
EMDN Code
P09120402 Screws
GMDN Term
Orthopaedic bone screw (non-sliding)
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3040
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 6 Millimeter
Length — 220 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
BONE FIXATION SCREWS, TENDONS AND LIGAMENTS SCREWS
943570
GUDID
1
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Orthopaedic bone pin, non-bioabsorbable

Cleared under the same submission (K955848)

Show all (12)

Other devices from Orthofix, Inc.

See all devices from Orthofix, Inc. →

Properties

  • Single Use
  • Implantable
  • Sutures
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Reusable: 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
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No