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Na 107-018-9060

by Biedermann Motech GmbH & Co. KG

Ref 107-018-9060Model MOSS Family

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

CE MDR CE MDD

Valid until

6 Dec 2028

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

2 certificates

Certifier DQS Medizinprodukte GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number42508696000010009E Basic UDI-DI 04250869643214UDI-DIDate15 Jul 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number42508696000010009E Basic UDI-DI 04250869643214UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250869643214 UDI-DI Date28 Jan 2020ListedStatusListed GUDID: in commercial distribution

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 1000319809 Active

    Technical documentation EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    7 Jul 2026
    Expires
    6 Jul 2031
  • 1000319811 Active Supplemented

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    7 Jul 2026
    Expires
    6 Dec 2028
    Reason
    Add device or group

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Spinal bone screw, non-bioabsorbable
Device Name
107-018-9060
Model / Ref / Catalog
107-018-9060, MOSS Family
Primary DI / UDI-DI
04250869643214
Basic UDI-DI
42508696000010009E, B-04250869643214
510(k) Number
FDA Product Code
NKB
EMDN Code
P09070302 Thoracolumbosacral fixation systems
GMDN Term
Spinal bone screw, non-bioabsorbable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3070
EU market of registration
Germany
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 IIb
GUDID
Class II

Related devices

Category: Spinal bone screw, non-bioabsorbable

Cleared under the same submission (K181821)

Show all (12)

Other devices from Biedermann Motech GmbH & Co. KG

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Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (21)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: 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
  • 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