SP-CL Hip Stem

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 177-401/35Model Hip stem, CaP coating, uncemented, Ti6Al4V, standarized, CCD 135°

by WALDEMAR LINK GmbH & Co. KG

Identity

Trade Name: SP-CL Hip Stem FDA UDI
Generic Name: Coated hip femur prosthesis, modular FDA UDI
Device Name: SP-CL Hip Stem EUDAMED
Hip Prosthesis Stem, Taper 12 / 14 FDA UDI
Model / Reference: 177-401/35 EUDAMEDFDA UDI
Hip stem, CaP coating, uncemented, Ti6Al4V, standarized, CCD 135° EUDAMED
Description: Hip Prosthesis Stem, Taper 12 / 14 FDA UDI

Identifiers

Primary DI / UDI-DI: 04026575424214 EUDAMEDFDA UDI
Basic UDI-DI: 4026575-1-HSP-006004-WX EUDAMED
510(k) Number: K161840 FDA UDI
FDA Product Code: MEH FDA UDI
LZO FDA UDI
EMDN Code: P090804010202 UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, ANATOMICAL EUDAMED
GMDN Term: Coated hip femur prosthesis, modular FDA UDI

Classification

Device Class: Class III EUDAMED
Class II FDA UDI
Regulation Number: 888.3353 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Coated hip femur prosthesis, modular

SP-CL Hip Stem by WALDEMAR LINK GmbH & Co. KG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Coated hip femur prosthesis, modular.

ABG — Howmedica Osteonics Corp. · Class II
Z1™ Hip System — Zimmer, Inc. · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
VerSys® — Zimmer, Inc. · Class II
CATALYSTEM — Smith & Nephew, Inc. · Class II
Everglade Stem, Standard Offset — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
Excia® L — AESCULAP, INC. · Class II
SYNERGY — Smith & Nephew, Inc. · Class II

Cleared under the same submission

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: WALDEMAR LINK GmbH & Co. KG

Sources (2)

FDA UDI b265d969-f3d8-4d0c-840f-091a71e4d806 34 fields · synced Oct 6, 2026
EUDAMED bd22ee67-2bc6-49fe-8d80-23b4b363d730 61 fields · synced Oct 6, 2026