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Navigated Instruments +1 more model

FDA UDI

Class II (US FDA UDI)

by Orthofix US LLC

Identity

Trade Name
NAVIGATED INSTRUMENTS;FIREBIRD NXG FDA UDI
Generic Name
Growth-correction orthopaedic fixation plate kit FDA UDI
Device Name
CANNULATED AWL, NAVIGATED BL FDA UDI
Model / Reference
36-1321 FDA UDI
Description
CANNULATED AWL, NAVIGATED BL FDA UDI

Identifiers

Primary DI / UDI-DI
18257200119493 FDA UDI
510(k) Number
K172115 FDA UDI
FDA Product Code
OLO FDA UDI
GMDN Term
Growth-correction orthopaedic fixation plate kit FDA UDI
Models / Variants
Navigated Instruments FDA UDI
firebird Nxg 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

No

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Growth-correction orthopaedic fixation plate kit

Navigated Instruments +1 more model by Orthofix US LLC — Class II — FDA UDI — listed in FDA GUDID — 2 models — regulatory data on deviCERTS

Similar devices

Also classified as Growth-correction orthopaedic fixation plate kit.

Cleared under the same submission

K172115 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthofix US LLC

Sources (1)

  • FDA UDI 49b68e37-e6e2-419e-918f-8780b34ea6ae 35 fields · synced Jun 1, 2026