Skip to content

Spinal Inner Fixation System

by Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. 180 variants

Ref 21215545

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K222031↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69371154424917D Basic UDI-DI 06941675448916UDI-DIDate4 Dec 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK222031 Date28 Oct 2022IssuedStatusActive

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

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Device Name
MISS Polyaxial Pedicle Screws / MISS Coaxial Pedicle Screw / Rods / Set screw: self breaking screws
Model / Reference
21215545
Primary DI / UDI-DI
06941675448916
Basic UDI-DI
69371154424917D
EMDN Code
P09070302 Thoracolumbosacral fixation systems
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000043758
Authorised representative
MedPath GmbH DE-AR-000000087

Related devices

Category: Spinal bone screw, non-bioabsorbable

Other devices from Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.

See all devices from Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. →

Properties

  • Implantable
  • Sutures

Other properties (12)

  • 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