VELYS Hip Navigation

FDA UDI

Class II (US FDA UDI)

by Depuy Orthopaedics, Inc.

Identity

Trade Name: VELYS Hip Navigation FDA UDI
Generic Name: Orthopaedic stereotactic surgery system FDA UDI
Device Name: VELYS Hip Navigation for Windows FDA UDI
Model / Reference: 451580051 FDA UDI
Description: VELYS Hip Navigation for Windows FDA UDI

Identifiers

Catalog Number: 451580051 FDA UDI
Primary DI / UDI-DI: 10603295522850 FDA UDI
510(k) Number: K160284 FDA UDI
FDA Product Code: LLZ FDA UDI
HAW FDA UDI
GMDN Term: Orthopaedic stereotactic surgery system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.2050 FDA UDI
882.4560 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

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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Orthopaedic stereotactic surgery system

VELYS Hip Navigation by Depuy Orthopaedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic stereotactic surgery system.

TRIGEN — Smith & Nephew, Inc. · Class II
PULSE — Nuvasive, Inc. · Class II
KneePlus — PIXEE MEDICAL · Class II
intellijoint HIP® — Intellijoint Surgical Inc · Class II
PULSE — Nuvasive, Inc. · Class II
Navigation Unit Kit — GYDER SURGICAL PTY LTD · Class II
StealthStation S8 Spine — MEDTRONIC NAVIGATION, INC. · Class II
WatchTower — Intai Technology Corporation · Class II

Cleared under the same submission

K160284 also covers:

VELYS Hip Navigation — DEPUY ORTHOPAEDICS, INC.

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: Depuy Orthopaedics, Inc.

Sources (1)

FDA UDI f660ff35-5c09-421a-b410-9c192f5ad823 36 fields · synced Jun 8, 2026