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SP-CL Hip Stem

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 177-151/26Model Hip stem, CpTi coating, uncemented, Ti6Al4V, standarized, CCD 126°

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
177-151/26 EUDAMEDFDA UDI
Hip stem, CpTi coating, uncemented, Ti6Al4V, standarized, CCD 126° EUDAMED
Description
Hip Prosthesis Stem, Taper 12 / 14 FDA UDI

Identifiers

Catalog Number
177-151/26 FDA UDI
Primary DI / UDI-DI
04026575260188 EUDAMEDFDA UDI
Basic UDI-DI
4026575-1-HSP-006001-WN 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

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

Cleared under the same submission

K161840 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
WALDEMAR LINK GmbH & Co. KG

Sources (2)

  • FDA UDI 0e4b9a6e-9ad7-43ab-a7fa-639084c4f40a 35 fields · synced Oct 6, 2026
  • EUDAMED 2d896222-7f60-4867-bd56-6a2058301ee3 61 fields · synced Jul 9, 2026