← Back to catalogue

Navigated Instruments +1 more model

FDA UDI

Class II (US FDA UDI)

by Orthofix US LLC

Identity

Trade Name
NAVIGATED INSTRUMENTS;PHOENIX SFS FDA UDI
Generic Name
Growth-correction orthopaedic fixation plate kit FDA UDI
Device Name
7.5MM, CANNULATED TAP, PHOENIX NAVIGATED MDT FDA UDI
Model / Reference
20-1217 FDA UDI
Description
7.5MM, CANNULATED TAP, PHOENIX NAVIGATED MDT FDA UDI

Identifiers

Primary DI / UDI-DI
18257200119455 FDA UDI
FDA Product Code
OLO FDA UDI
GMDN Term
Growth-correction orthopaedic fixation plate kit FDA UDI
Models / Variants
Navigated Instruments FDA UDI
phoenix Sfs 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Orthofix US LLC

Sources (1)

  • FDA UDI 5c2197e9-bdc4-4160-9a52-6a8e3b417245 34 fields · synced Jun 8, 2026