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Monster® Screw System

by Paragon 28 Inc. 101 variants

Ref P20-435-080F

Monster® Screw System (P20-435-080F) is a Class IIb device made by Paragon 28, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI 0889795P2XIIB01NSUCMJX), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

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

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0889795P2XIIB01NSUCMJX Basic UDI-DI 00889795014764UDI-DIDate4 Nov 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Monster Screw System Implants
Model / reference
P20-435-080F
Primary DI / UDI-DI
00889795014764
Basic UDI-DI
0889795P2XIIB01NSUCMJX
EMDN code
P09120602 Cancellous screws
Device class
Class IIb
EU registration type
Standard device
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000030676
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Paragon 28

See all devices from Paragon 28 →

Properties

  • Sterilise before use
  • Implantable
  • Sutures
Other properties (12, all answered No)