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Pro 705462

by Stryker Corp.

Part of a family of 25 devices: see the family page

Ref 705462Model 08858251002611SM

Pro 705462 is a Class I device made by Stryker Corp., registered in EUDAMED on 25 Aug 2026 (Basic UDI-DI 08858251002611SM) and listed in FDA GUDID since 24 Sep 2018 (UDI-DI 07613327131888), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002611SM Basic UDI-DI 07613327131888UDI-DIDate25 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327131888 UDI-DI Date24 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002611SM registered 25 Aug 2026 Active
  • FDA GUDID UDI-DI 07613327131888 listed 24 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327131888
  2. Registered EUDAMED 08858251002611SM

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  • Withdrawn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
Pro
Generic name
Bone approximation clamp
Device name
Pro Instruments - Reduction Instrumentation - Class I - Reusable - Non Sterile
Model / Ref / Catalog
705462, 08858251002611SM
Primary DI / UDI-DI
07613327131888
Basic UDI-DI
08858251002611SM
Direct marketing DI
07613327131888
FDA product code
HXD
EMDN code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN term
Bone approximation clamp
Device class
Class I
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Bone approximation clamp

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
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (19, all answered No)