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deflector JSBSR15012

by Joimax GmbH

Ref JSBSR15012

deflector JSBSR15012 is a device classified as Class IIa in the EU and Class I in the US made by Joimax GmbH, registered in EUDAMED on 21 May 2026 (Basic UDI-DI 42503371SPINAOHK) and listed in FDA GUDID since 25 Jul 2025 (UDI-DI 04250337120803), active as of 12 Nov 2026.

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

CE MDR

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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number42503371SPINAOHK Basic UDI-DI 04250337120803UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250337120803 UDI-DI Date25 Jul 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 42503371SPINAOHK registered 21 May 2026 Active
  • FDA GUDID UDI-DI 04250337120803 listed 25 Jul 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250337120803
  2. Registered EUDAMED 42503371SPINAOHK

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
AO Spinner Blade EUDAMED
deflector GUDID
Generic name
Spinal shaver system blade
Model / Ref / Catalog
JSBSR15012
Primary DI / UDI-DI
04250337120803
Basic UDI-DI
42503371SPINAOHK
Direct marketing DI
04250337120803
FDA product code
HWE
EMDN code
Z12130585 Motorised orthopaedic surgery system instruments - consumables
GMDN term
Spinal shaver system blade
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4820
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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

Related devices

Category: Spinal shaver system blade

Similar devices in this category

Other devices filed under MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS.

Other devices from Joimax GmbH

See all devices from Joimax GmbH →

Properties

  • Supplied sterile
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)