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Pantheon System Salvage Stem (Cemented)

by Adler Ortho SpA 11 variants

Ref 0280513Model PANTHEON SALVAGE CEMENTED STEM L 115 Ø 13

Pantheon System Salvage Stem (Cemented) (0280513) is a device classified as Class III in the EU and Class II in the US made by Adler Ortho SpA, registered in EUDAMED on 16 Jun 2026 (Basic UDI-DI B-08052275306273) and listed in FDA GUDID since 3 Mar 2025 (UDI-DI 08052275306273), active as of 25 Oct 2026.

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

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08052275306273 Basic UDI-DI 08052275306273UDI-DIDate16 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08052275306273 UDI-DI Date3 Mar 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08052275306273 registered 16 Jun 2026 Active
  • FDA GUDID UDI-DI 08052275306273 listed 3 Mar 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08052275306273
  2. Registered EUDAMED B-08052275306273

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Pantheon Pfr EUDAMED
Pantheon System GUDID
Generic name
Revision uncoated femoral stem prosthesis
Model / Ref / Catalog
PANTHEON SALVAGE CEMENTED STEM L 115 Ø 13, 0280513, Salvage Stem (Cemented)
Primary DI / UDI-DI
08052275306273
Basic UDI-DI
B-08052275306273
FDA product code
LPH, JDI, LZO, MBL
EMDN code
P09080404 Large resections femoral stems
GMDN term
Revision uncoated femoral stem prosthesis
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3358, 888.3350, 888.3353
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
PANTHEON SALVAGE CEMENTED STEM L 115 Ø 13
0280513
GUDID
Salvage Stem (Cemented)
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III 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: Revision uncoated femoral stem prosthesis

Similar devices in this category

Other devices filed under HIP PROSTHESES FEMORAL COMPONENTS.

Other devices from Adler Ortho SpA

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)