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OSTEOPAL® plus

by Heraeus Medical LLC

Ref 66045747_LegacyModel 1x20

OSTEOPAL® plus (66045747) is a device classified as Class IIb in the EU and Class II in the US made by Heraeus Medical LLC, registered in EUDAMED on 22 Apr 2026 (Basic UDI-DI B-04260102132597), cleared under FDA 510(k) K153737 on 22 Apr 2016 and listed in FDA GUDID since 10 Aug 2020 (UDI-DI 04260102132597), active as of 9 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 9 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K153737

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04260102132597 Basic UDI-DI 04260102132597UDI-DIDate22 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260102132597 UDI-DI Date10 Aug 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK153737 Date22 Apr 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04260102132597 registered 22 Apr 2026 Active
  • FDA 510(k) K153737 decided 22 Apr 2016 Active
  • FDA GUDID UDI-DI 04260102132597 listed 10 Aug 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K153737
  2. Listed FDA GUDID 04260102132597
  3. Registered EUDAMED B-04260102132597

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
OSTEOPAL plus EUDAMED
Osteopal® GUDID
Generic name
Orthopaedic cement, non-antimicrobial
Model / Ref / Catalog
1x20 EUDAMED
66045747_Legacy EUDAMED
plus GUDID
66045747 GUDID
Primary DI / UDI-DI
04260102132597
Basic UDI-DI
B-04260102132597
510(k) Number
FDA product code
LOD, NDN
EMDN code
P099001 Orthopaedic prostheses cements and accessories for mixing
GMDN term
Orthopaedic cement, non-antimicrobial
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3027
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
1x20
66045747_Legacy
GUDID
plus
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthopaedic cement, non-antimicrobial

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES CEMENTS AND ACCESSORIES FOR MIXING.

Other devices from Heraeus Medical LLC

See all devices from Heraeus Medical LLC →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)