Unicondylar Sled Prosthesis

FDA UDI

Class II (US FDA UDI)

by WALDEMAR LINK GmbH & Co. KG

Identity

Trade Name: Unicondylar Sled Prosthesis FDA UDI
Generic Name: Coated unicondylar knee tibia prosthesis FDA UDI
Device Name: Tibial Component Metal-Backed PE-PorEx FDA UDI
Model / Reference: 15-2230/11 FDA UDI
Description: Tibial Component Metal-Backed PE-PorEx FDA UDI

Identifiers

Catalog Number: 15-2230/11 FDA UDI
Primary DI / UDI-DI: 04026575429219 FDA UDI
510(k) Number: K152431 FDA UDI
K212742 FDA UDI
FDA Product Code: HSX FDA UDI
GMDN Term: Coated unicondylar knee tibia prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3520 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Coated unicondylar knee tibia prosthesis

Unicondylar Sled Prosthesis by WALDEMAR LINK GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coated unicondylar knee tibia prosthesis.

RESTORIS PST — MAKO Surgical Corp. · Class II
Symmetric Total Knee Tibial Tray — Signal Medical Corp. · Class II
Uni Tibial Tray — Signal Medical Corp. · Class II
RESTORIS PST — MAKO Surgical Corp. · Class II
RESTORIS PST — MAKO Surgical Corp. · Class II
Alliant Biotech — Medisurge · Class II
RESTORIS PST — MAKO Surgical Corp. · Class II
Alliant Biotech — Medisurge · Class II

Cleared under the same submission

K152431 also covers:

K212742 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
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 (1)

FDA UDI 98fe3de3-add6-4f6a-8e55-a770a3529fb4 35 fields · synced May 29, 2026