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702816

by Stryker Corp.

Ref 702816Model 08858251003058SQ

702816 is a device classified as Class IIa in the EU and Class I in the US made by Stryker Corp., registered in EUDAMED on 2 Oct 2026 (Basic UDI-DI 08858251003058SQ) and listed in FDA GUDID since 24 Sep 2020 (UDI-DI 07613153054184), active as of 25 Oct 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251003058SQ Basic UDI-DI 07613153054184UDI-DIDate2 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613153054184 UDI-DI Date24 Sep 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251003058SQ registered 2 Oct 2026 Active
  • FDA GUDID UDI-DI 07613153054184 listed 24 Sep 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613153054184
  2. Registered EUDAMED 08858251003058SQ

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  • Withdrawn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
Sps
Generic name
Bone-resection orthopaedic reamer, reusable
Device name
Sps Instruments - Opening Instrumentation - Class Iia - Non Sterile
Model / Ref / Catalog
702816, 08858251003058SQ
Primary DI / UDI-DI
07613153054184
Basic UDI-DI
08858251003058SQ
Direct marketing DI
07613153054184
FDA product code
LXH
EMDN code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN term
Bone-resection orthopaedic reamer, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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: Bone-resection orthopaedic reamer, reusable

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Sterilise before use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)