LINK Instrument

FDA UDI

Class II (US FDA UDI)

by WALDEMAR LINK GmbH & Co. KG

Identity

Trade Name: LINK Instrument FDA UDI
Generic Name: Orthopaedic broach FDA UDI
Device Name: Bone Compressor FDA UDI
Model / Reference: 165-111/11 FDA UDI
Description: Bone Compressor FDA UDI

Identifiers

Catalog Number: 165-111/11 FDA UDI
Primary DI / UDI-DI: 04026575433865 FDA UDI
510(k) Number: K161840 FDA UDI
FDA Product Code: MEH FDA UDI
LZO FDA UDI
GMDN Term: Orthopaedic broach FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 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

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: Orthopaedic broach

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

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iNSitu™ Hip System — Nextstep Arthropedix · Class I
TEMA Elbow — Limacorporate · Class II

Cleared under the same submission

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 e126ede1-4880-47ea-9da2-5ddadf42f9a2 35 fields · synced Jun 8, 2026