Skip to content

Instrument 6704-9-350

by Howmedica Osteonics Corp.

Ref 6704-9-350Model 08858250000792SM

Instrument 6704-9-350 is a Class I device made by Howmedica Osteonics Corp., registered in EUDAMED on 19 Jun 2026 (Basic UDI-DI 08858250000792SM) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 07613327223279), 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 Number08858250000792SM Basic UDI-DI 07613327223279UDI-DIDate19 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327223279 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858250000792SM registered 19 Jun 2026 Active
  • FDA GUDID UDI-DI 07613327223279 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327223279
  2. Registered EUDAMED 08858250000792SM

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  • Withdrawn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
Instrument
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
TF-018 Class I (r) - Tensioning
Model / Ref / Catalog
6704-9-350, 08858250000792SM
Primary DI / UDI-DI
07613327223279
Basic UDI-DI
08858250000792SM
Direct marketing DI
07613327223279
FDA product code
LXH
EMDN code
L091106 Instruments for the preparation of tissue implants in orthopaedic and traumatological surgery, reusable
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class I
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

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Similar devices in this category

Other devices filed under INSTRUMENTS FOR THE PREPARATION OF TISSUE IMPLANTS IN ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY, REUSABLE.

Other devices from Howmedica Osteonics Corp.

See all devices from Howmedica Osteonics 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)