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Ortho Solutions Extremity Fixation Implants for Osteosysnthesis OS310808

by Ortho Solutions Holdings Limited

Ref OS310808Model Screw Systems

Withdrawn Withdrawn in European Union.

Was authorized under CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDD)

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/MDD EUDAMED NumberB-05055662917192 Basic UDI-DI 05055662917192UDI-DIDate13 Jun 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number05055662917192 UDI-DI Date16 May 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

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  • Withdrawn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  • European Union CE/MDD Withdrawn
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Ortho Solutions Extremity Fixation Implants for Osteosysnthesis
Generic Name
Orthopaedic bone staple, non-adjustable
Device Name
Varisation Staples
Model / Ref / Catalog
OS310808, Screw Systems
Primary DI / UDI-DI
05055662917192
Basic UDI-DI
B-05055662917192
510(k) Number
FDA Product Code
HRS
EMDN Code
P09120101 Osteosynthesis staples
GMDN Term
Orthopaedic bone staple, non-adjustable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3030
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

Related devices

Category: Orthopaedic bone staple, non-adjustable

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

  • Sterile
  • Single Use
  • Implantable NoEUDAMEDYesGUDID
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • 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
  • Manufacturing Date: No