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Osteopal® V

by Heraeus Medical LLC

Ref 66031896_LegacyModel 1x20

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 Withdrawn in European Union.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

CE MDD, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is 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) K050085

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 9 Nov 2026.

Overview

Osteopal V is an orthopedic cement used for vertebroplasty and kyphoplasty procedures. It is a type of bone cement made from methylmethacrylate, polymethylmethacrylate (PMMA), or esters of methacrylic acid.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04260102130494 Basic UDI-DI 04260102130494UDI-DIDate20 May 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number04260102130494 UDI-DI Date10 Aug 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK050085 Date14 Sep 2005DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04260102130494 registered 20 May 2026 Withdrawn
  • FDA 510(k) K050085 decided 14 Sep 2005 Active
  • FDA GUDID UDI-DI 04260102130494 listed 10 Aug 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K050085
  2. Listed FDA GUDID 04260102130494
  3. Registered EUDAMED B-04260102130494

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/MDD Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Osteopal V EUDAMED
Osteopal® GUDID
Generic name
Orthopaedic cement, non-antimicrobial
Model / Ref / Catalog
1x20 EUDAMED
66031896_Legacy EUDAMED
V GUDID
66031896 GUDID
Primary DI / UDI-DI
04260102130494
Basic UDI-DI
B-04260102130494
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)
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
1x20
66031896_Legacy
GUDID
V
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)