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Pello 629011204012

by Stryker Corp.

Part of a family of 16 devices: see the family page

Ref 6290-112-040-12Model 08858251002011RP

Pello 629011204012 (6290-112-040-12) is a device classified as Class IIa in the EU and Class I in the US made by Stryker Corp., registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI 08858251002011RP) and listed in FDA GUDID since 13 Sep 2023 (UDI-DI 07613327576696), active as of 7 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002011RP Basic UDI-DI 07613327576696UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327576696 UDI-DI Date13 Sep 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002011RP registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 07613327576696 listed 13 Sep 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327576696
  2. Registered EUDAMED 08858251002011RP

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  • Withdrawn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
Pello
Generic name
Surgical saw blade, sagittal, single-use
Device name
Pello Cutting Accessories
Model / Ref / Catalog
08858251002011RP, 6290-112-040-12, 629011204012
Primary DI / UDI-DI
07613327576696
Basic UDI-DI
08858251002011RP
FDA product code
GFA
EMDN code
V010302 Blades without safety systems, single-use - not included in other classes
GMDN term
Surgical saw blade, sagittal, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4820
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
08858251002011RP
6290-112-040-12
GUDID
629011204012
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: Surgical saw blade, sagittal, single-use

Similar devices in this category

Other devices filed under BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)