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Ortho Solutions Extremity Fixation Implants for Osteosysnthesis OS310100

by Ortho Solutions Holdings Limited

Ref OS310100Model Non-Invasive Devices and Accessories

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number50556629257M Basic UDI-DI 05055662923469UDI-DIDate12 Jun 2026RegisteredStatusActive EUDAMED: not on the EU market
United StatesGUDID listing GUDID Number05055662923469 UDI-DI Date13 Oct 2017ListedStatusListed 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

1 recall · FDA

    • Terminated Z-2835-2016 FDA Class II initiated 21 Jul 2016 on shared 510(k) K111678

    Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
Ortho Solutions Extremity Fixation Implants for Osteosysnthesis
Generic Name
Instrument tray, reusable
Device Name
Class I Instruments
Model / Ref / Catalog
OS310100, Non-Invasive Devices and Accessories
Primary DI / UDI-DI
05055662923469
Basic UDI-DI
50556629257M
Direct Marketing DI
05055662923469
510(k) Number
FDA Product Code
HRS
EMDN Code
S010401 Trays, baskets, tubs for sterilisation and their components
GMDN Term
Instrument tray, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Category: Instrument tray, reusable

Cleared under the same submission (K111678)

Show all (12)

Other devices from Ortho Solutions Holdings Limited

See all devices from Ortho Solutions Holdings Limited →

Properties

  • Reusable
  • Lot / Batch Number

Other properties (22)

  • 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
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No