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OrthAlign Plus

FDA UDI

Class II (US FDA UDI)

by Orthalign, Inc.

Identity

Trade Name
OrthAlign Plus FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
OrthAlign Plus Unit - Gap Balancing (US) FDA UDI
Model / Reference
403001-08-US FDA UDI
Description
OrthAlign Plus Unit - Gap Balancing (US) FDA UDI

Identifiers

Catalog Number
403001-08-US FDA UDI
Primary DI / UDI-DI
00810832031987 FDA UDI
FDA Product Code
OLO FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, reusable 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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthopaedic surgical procedure kit, non-medicated, reusable

OrthAlign Plus by Orthalign, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic surgical procedure kit, non-medicated, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthalign, Inc.

Sources (1)

  • FDA UDI db7c1054-86e9-4e4f-84cf-b93b7005d8ab 36 fields · synced Jun 8, 2026