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Fusion Nail

FDA UDI

Class II (US FDA UDI)

by WALDEMAR LINK GmbH & Co. KG

Identity

Trade Name
Fusion Nail FDA UDI
Generic Name
Knee arthrodesis prosthesis FDA UDI
Device Name
Fusion Nail, modular FDA UDI
Model / Reference
15-0028/08 FDA UDI
Description
Fusion Nail, modular FDA UDI

Identifiers

Catalog Number
15-0028/08 FDA UDI
Primary DI / UDI-DI
04026575175222 FDA UDI
510(k) Number
K151008 FDA UDI
FDA Product Code
LWJ FDA UDI
JDI FDA UDI
LZO FDA UDI
KRO FDA UDI
GMDN Term
Knee arthrodesis prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3360 FDA UDI
888.3350 FDA UDI
888.3353 FDA UDI
888.3510 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Category: Knee arthrodesis prosthesis

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

Similar devices

Also classified as Knee arthrodesis prosthesis.

Cleared under the same submission

K151008 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 (1)

  • FDA UDI 33119e26-8afc-4c18-b141-b79d4026f84c 36 fields · synced May 30, 2026