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Hana/ProFx Femoral Hook Support REFURB 6850-110R

by Mizuho Orthopedic Systems, Inc.

Ref 6850-110

Active European Union. Also listed in GUDID (US), partly in commercial distribution.

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0842430158956Y Basic UDI-DI 00842430106804UDI-DIDate2 May 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00842430106804 UDI-DI Date6 Sep 2019ListedStatusListed GUDID: 1 of 2 UDI-DIs in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Hana/ProFx Femoral Hook Support EUDAMEDGUDID
Hana/ProFx Femoral Hook Support REFURB GUDID
Generic Name
Femur lifter, manual
Device Name
Operating Table Accessories
Model / Ref / Catalog
6850-110, 6850-110R
Primary DI / UDI-DI
00842430106804, 00842430111334
Basic UDI-DI
0842430158956Y
FDA Product Code
JEA
EMDN Code
Z12011280 Patient positioning instruments - hardware accessories
GMDN Term
Femur lifter, manual
Device Class
Class I
Regulation Number
878.4960
EU market of registration
Germany
GUDID distribution status
Not in Commercial Distribution (UDI-DI 00842430111334)
In Commercial Distribution (UDI-DI 00842430106804)
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from Mizuho Orthopedic Systems, Inc.

See all devices from Mizuho Orthopedic Systems, Inc. →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No