KneeAlign 2

FDA UDI

Class II (US FDA UDI)

by Orthalign, Inc.

Identity

Trade Name: KneeAlign 2 FDA UDI
Generic Name: Orthopaedic stereotactic surgery system FDA UDI
Device Name: KneeAlign 2 Unit FDA UDI
Model / Reference: 133631 FDA UDI
Description: KneeAlign 2 Unit FDA UDI

Identifiers

Catalog Number: 133631 FDA UDI
Primary DI / UDI-DI: 00858704006008 FDA UDI
FDA Product Code: OLO FDA UDI
GMDN Term: Orthopaedic stereotactic surgery system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Orthopaedic stereotactic surgery system

KneeAlign 2 by Orthalign, 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

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: Orthalign, Inc.

Sources (1)

FDA UDI dfaf658a-f618-46d3-90f7-18080926324f 36 fields · synced May 30, 2026