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SP-CL Hip Stem 177-612/26

by WALDEMAR LINK GmbH & Co. KG

Ref 177-612/26Model Hip stem, CaP coating, uncemented, Ti6Al4V, lateralized, CCD 126°

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

24 Jan 2029

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier DNV MEDCERT GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4026575-1-HSP-006006-X5 Basic UDI-DI 04026575184750UDI-DIDate7 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026575184750 UDI-DI Date16 May 2017ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 13783GB450240125 Active

    Technical documentation EU MDR

    Certifier
    DNV MEDCERT GmbH 0482
    Issued
    25 Jan 2024
    Expires
    24 Jan 2029

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
SP-CL Hip Stem
Generic Name
Coated hip femur prosthesis, modular
Model / Reference
177-612/26, Hip stem, CaP coating, uncemented, Ti6Al4V, lateralized, CCD 126°
Primary DI / UDI-DI
04026575184750
Basic UDI-DI
4026575-1-HSP-006006-X5
510(k) Number
FDA Product Code
MEH, LZO
EMDN Code
P090804010202 Uncemented femoral stems for primary implant, with fixed neck, anatomical
GMDN Term
Coated hip femur prosthesis, modular
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3353
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Cleared under the same submission (K161840)

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No