LinkSymphoKnee

FDA UDI

Class I (US FDA UDI)

by WALDEMAR LINK GmbH & Co. KG

Identity

Trade Name: LinkSymphoKnee FDA UDI
Generic Name: Knee tibia prosthesis trial, reusable FDA UDI
Device Name: Knee tibia prosthesis trial - LinkSymphoKnee FDA UDI
Model / Reference: 881-269/11 FDA UDI
Description: Knee tibia prosthesis trial - LinkSymphoKnee FDA UDI

Identifiers

Primary DI / UDI-DI: 04026575534586 FDA UDI
FDA Product Code: HWT FDA UDI
GMDN Term: Knee tibia prosthesis trial, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Knee tibia prosthesis trial, reusable

LinkSymphoKnee by WALDEMAR LINK GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Knee tibia prosthesis trial, reusable.

JOURNEY — Smith & Nephew, Inc. · Class II
INSTRUMENT — Howmedica Osteonics Corp. · Class II
INSTRUMENT — Howmedica Osteonics Corp. · Class I
U2™ Knee — UNITED ORTHOPEDIC CORP. · Class II
ACS® — implantcast GmbH · Class I
SIGMA — DEPUY ORTHOPAEDICS, INC. · Class I
SIGMA — DEPUY ORTHOPAEDICS, INC. · Class I
INSTRUMENT — Howmedica Osteonics Corp. · Class I

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 I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: WALDEMAR LINK GmbH & Co. KG

Sources (1)

FDA UDI 8616008a-f96c-413a-a79d-24f41de2da78 33 fields · synced May 30, 2026