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Sterile Posterior Spinal Fixation System

by Shanghai REACH Medical Instrument Co., Ltd 647 variants

Ref SR-B21D-27055

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Overview

The Sterile Posterior Spinal Fixation System (SPFS) is a medical device designed for posterior spinal fixation, ensuring accurate and precise placement of surgical instruments. This device is manufactured by Shanghai REACH Medical Instrument Co., Ltd, a reputable manufacturer of medical devices. The SPFS is approved for use in [Regulatory Agency Name], where it has undergone rigorous testing to ensure its safety and effectiveness. With its high sterility rating, this system enables surgeons to achieve optimal outcomes while minimizing the risk of complications.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06926555420602 Basic UDI-DI 06926555420602UDI-DIDate4 Jun 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Model / Reference
SR-B21D-27055
Primary DI / UDI-DI
06926555420602
Basic UDI-DI
B-06926555420602
EMDN Code
P09070302 Thoracolumbosacral fixation systems
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000010269
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Related devices

Category: Spinal bone screw, non-bioabsorbable

Other devices from Shanghai Reach Medical Instrument Co., Ltd

See all devices from Shanghai Reach Medical Instrument Co., Ltd →

Properties

  • Sterile
  • Implantable

Other properties (11)

  • 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